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clinical trials disclosure services

Thousands of Records Posted, >90% without NIH Comments

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Clinical Trials Disclosure

Finding experienced resources to register and report your clinical trial, provide document redaction services, or locating the right team for end-to-end management and support of an entire portfolio of studies can be difficult.

Our Clinical Trials Disclosure (CTD) experts are here for you.

Our dedicated team of disclosure experts have successfully maintained thousands of studies across multiple registries/therapeutic areas and redacted thousands of pages to meet a myriad of transparency obligations (including EU Clinical Trial Regulation (CTR)/Clinical Trial Information System (CTIS), Policy 0070, and Health Canada Public Release of Clinical Information (PRCI)).

All Clinical Trials Disclosure Services

Let our seasoned project managers and authors navigate you through the ever-evolving clinical trials disclosure landscape and build a custom solution to achieve your clinical trials disclosure and transparency objectives.

Document Redaction/Anonymization

ProPharma provides resources, guidance, and support for both anonymization and document redaction.

Document Redaction

ProPharma’s redaction specialists leverage a proprietary redaction software platform to review, assess, and redact thousands of pages of documents subject to data anonymization and transparency initiatives through the application of both industry standards (e.g., TransCelerate) and agency- and client-specific guidelines across the following types of requests:

  • Regulatory agencies
    • European Medicines Agency (EMA) Policy 0043 (EU Access to Documents), Policy 0070, and EU Clinical Trial Regulation (CTR) (via Clinical Trial Information System (CTIS))
    • U.S Food and Drug Administration (FDA) FDAAA Section 801 and Final Rule
    • Health Canada Public Release of Clinical Information (PRCI)
  • The scientific community: journal publication requests
  • The broader public: third party requests to satisfy internal company transparency initiatives

ProPharma can also provide QC review of documents that are already redacted, to ensure all required information has been appropriately redacted consistently across all documents.

Our experienced redaction specialists can manage internal review and approval processes of marked for redaction documents to deliver a final, marked for redaction version of all applicable documents

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In support of EU CTIS submissions, ProPharma has direct experience providing the following redaction services and support:

  • Redaction of all core (EU wide) and supporting documents, as well as country- and site-specific documents (national) needed for submission (Part I and Part II)
  • Redaction of amended documents following Member State Requests for Information (RFIs)
  • Redaction of site-specific, native-language documents
  • Rapid response teams to ensure RFI response timelines are met within all required turnaround times

In support of EMA Policy 0070 and Health Canada PRCI redactions, ProPharma provides the following comprehensive redaction services and support:

  • Development of redaction strategy/report
  • SME consultation to prepare for health authority interactions
  • Application of color-specific overlays for personal data and commercially confidential information (CCI) in compliance with either European Medicines Agency (EMA) or Health Canada requirements
  • Development of CCI and personally protected information (PPI) checklists
  • Performance of online searches for potential CCI in the public domain
  • Internal reviews to ensure consistency across documents
  • Completion of justification table for CCI
  • Preparation and/or review of anonymization report

Anonymization

ProPharma has expert knowledge in both policies and the public release that guide anonymization and provides retrospective AND prospective anonymization services to anonymize data to acceptable, quantifiable levels without sacrificing data utility. With constant and clear communication and collaboration, ProPharma provides the following anonymization services:

  • Development of an anonymization plan
  • Quantitative risk assessment 
  • Multiple application options: randomization, generalization, masking
  • Robust QC procedures for all programming
  • Internal testing to maintain utility and determine risk of re-identification
  • Development of final anonymization report
  • Quick dataset turnaround time without sacrificing quality
Contact Us      See our Clinical Trials Disclosure FAQs  

Clinical Trial Registry Authoring

ProPharma provides resources and expert guidance in support of compliant clinical trial registry authoring across multiple global (including country-specific) registries.

Clinical trial registry authoring at ProPharma includes:

  • Initial protocol registration (protocol summary registration): initial review to determine what studies need to be registered, to which registry(ies), and within what specific timeframe
  • Ongoing registry maintenance (monthly/annual updates): track and manage each registry deliverable through the use of a customized client dashboard to ensure all applicable updates are completed and compliance is maintained
  • Clinical trials results: determination of in-scope vs. out-of-scope, timing of relevant results entry (i.e., final vs. interim reporting), and filing of certification of delay

Multiple independent, documented QC reviews are performed throughout the lifecycle of each deliverable, ensuring an accurate, high-quality, and compliant record is produced. All timelines and processes are adaptable and customizable to accommodate business needs.

Our vast clinical trial registry authoring experience includes but is not limited to the following individual registries:

  • ClinicalTrials.gov
  • EudraCT/EU CTIS
  • JapicCTI/jRCT
  • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
  • EU Post-Authorization Studies (PAS) Register
  • Individual country registries (e.g., CTRI, DRKS/BfArM)
  • Client-specific registries
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Key features of ProPharma's success in the clinical trial registry authoring space include:

  • ProPharma clinical trials disclosure authors are experts at distilling the scientific data from the source documents into the necessary form to meet all registry requirements.
  • ProPharma's registry authoring process is fully managed and supported internally
  • ProPharma's clinical trials disclosure authors drive the process, engaging stakeholder teams at pivotal times throughout
  • ProPharma's clinical trials disclosure authors are adept and seasoned project managers who effectively manage each project from start to finish
  • ProPharma can use client SOPs and processes/procedures, but has also developed internal SOPs and processes as well as the internal infrastructure and governance, which can be implemented to augment and support existing client procedures and fully operationalize the ProPharma team or leveraged to function completely independently
  • ProPharma proactively identifies trends in evolving changes in individual registry requirements and implements them to avoid future comments
Contact Us      See our Clinical Trials Disclosure FAQs  

Plain Language Authoring

ProPharma's experienced plain language team of experts works with clients to develop relevant and timely, non-promotional plain language documents including but not limited to:

  • Informed consent forms
  • Plain language protocol synopses (in compliance with EU CTR)
  • Plain language summaries (EU CTR, UK, etc.)

ProPharma's solutions-focused team of plain language experts also help clients develop the foundational documents and processes designed to ensure the success of their plain language program. These include (but are not limited to):

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  • Plain language templates: customized to individual client requirements, graphics and color scheme options, providing standardized text for information and awareness fields
  • Quality review checklists
  • Customized patient questionnaires (to be used during patient review/user testing to collect feedback designed to improve readability of each plain language document)
  • Implementation and execution of patient reviews/user tests
  • Plain language libraries: promotes efficiency in producing future plain language documents and can help with translational memory (TM) to reduce future costs

ProPharma's value proposition lies in the following formula for success in providing plain language authoring services:

  • Skilled plain-language authors with direct plain language experience encompassing multiple therapy areas, including but not limited to oncology, cardiovascular, endocrinology, nephrology, CNS, ophthalmology, and inflammation
  • Autonomously drive the document development process
  • Active participation in the plain language community to maintain health literacy knowledge and training through regular attendance at relevant disclosure conferences, workshops, etc.
  • Talented and experienced graphic artists to design and create custom graphics to facilitate visually aesthetic comprehension
  • Experienced engineers of patient review panels/user testing, assimilating feedback downstream to produce reader-friendly materials
  • Skilled architects in the design and implementation of portfolio-specific lay language libraries that provide a framework for future growth and maintenance
  • Leverage industry partnerships to provide certified, country-specific translation of plain language documents into approximately 40 different languages
Contact Us      See our Clinical Trials Disclosure FAQs  

Management Consultation 

ProPharma provides management consultation services in which we leverage our subject matter expertise and guidance to help you understand, interpret, and apply relevant legislation and regulations. Services include but are not limited to: 

  • Regulatory guidance 
  • Stakeholder education/training 
  • Disclosure audit/gap analysis 
  • Client process development and documentation 

ProPharma’s clinical trials disclosure SMEs work with clients to help determine what studies need to post, by when and to which registries, as well as what additional documentation (if any) may be needed to complete the registrations. We also provide guidance as to which studies may be eligible for extensions in reporting (i.e., Certification of Delay on Clinicaltrials.gov), assisting with the requests, as needed. 

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In addition, our expertise can be leveraged to conduct a gap analysis to identify any potential deviations in compliance, providing what support is needed to bring each study into full compliance. 

We also offer comprehensive stakeholder education and training, which can be implemented in a single department or across an entire client organization as needed to develop and/or implement disclosure policies and processes. We work with clients to develop individual training plans based on their business needs.

ProPharma remains embedded and actively involved in the clinical trials disclosure community, so that we can remain abreast of changes, incorporating them into our processes and informing our clients as needed. Our SMEs regularly attend conferences and workshops and are active members in organizations such as Drug Information Association (DIA), volunteering and participating in multiple ad hoc CTD working groups (e.g., EU CTIS working group, Policy 0070 working group, Country Registry Working Group, Final Rule Working Group, Avoiding PRS Comments Working Group, etc.).

Contact Us      See our Clinical Trials Disclosure FAQs  

Questions About Clinical Trials Disclosure?

Clinical Trials Disclosure Frequently Asked Questions

How are you successful in the clinical trials disclosure space?

 

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Highly experienced resources

The depth and breadth of experience in our resources comes from being embedded in the clinical trials disclosure space since its inception, authoring thousands of records across multiple registries and reviewing thousands of pages for redaction.

High quality of our deliverables

Through the use of a documented and systematic approach that builds quality into the document as it evolves through the lifecycle, >90% of records authored by ProPharma are made public with no regulatory review (NIH) comments, which is much higher than our competitors and has the added benefit of reducing the overall cost of the record.

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Collaborative and transparent working relationships

It’s a way of thinking that is ‘we’ and not ‘us’ and we believe in it.

We are highly visible to clients and offer a great client experience, developing long-term partnerships; our average client partnership is 5 years.

Value maximization

We have found that our extensive experience and resulting efficiencies gained from the ProPharma operational model and superior quality result in lower cost to clients.

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What is your clinical trials disclosure registry workflow?

We have mapped out an integrated process, with all documentation, governance, and infrastructure needed to enable immediate startup of any disclosure project.

The use of detailed step-by-step process maps, guidance documents, document templates, and other job aids ensures consistency, quality, and adherence to applicable regulations.

We work with each client to tailor and individualize the process and all accompanying documentation to accommodate any additional client specifications.

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IDENTIFY & REPORT

  • Review materials to identify applicable reportable information
  • Prepare compliant registry record
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ENGAGE

  • Early engagement of study team
  • Solicit and incorporate study team input, confirming alignment with study details
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REVIEW

  • Multiple internal reviews for both content and quality
  • Subject matter expert reviews to ensure compliance with applicable registry guidelines
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FINALIZE

  • Obtain final approval
  • Upload to registry

Additional Clinical Trials Disclosure Frequently Asked Questions

Click on frequently asked questions about ProPharma's clinical trials disclosures to learn about our experience and expertise.

We specialize in providing clinical trials disclosure services including redaction services to pharmaceutical/biotech companies of all sizes (including small, mid-size, and big pharma).

ProPharma recognizes that the recent increase in legislation broadening the scope of required transparency can be a challenge to navigate as you work to stay compliant while balancing your commercial obligations. 

In response, to this ProPharma developed a management consultation program as a complement to our clinical trial registry authoring and redaction services. Through this program, we provide expert consultation and guidance to help with understanding, interpreting, and applying the relevant regulations to individual programs and studies. 

In addition, we remain active participants in the clinical trials disclosure community, attending and participating in industry conferences, volunteering for working groups, attending workshops and seminars, and collaborating with industry partners to stay abreast of evolving trends. Whenever possible, we share that knowledge with our clients to ensure compliance and improve efficiency. 

In our vast experience, the overall process for developing a protocol registration or authoring a results posting can be highly variable and dependent on multiple factors. For that reason, our process timeline is flexible and can be modified to accommodate individual client needs such as study priority, team bandwidth, or other company needs, including compression of timelines to meet imminent compliance deadlines. 

As an example, provided all materials needed to produce a complaint posting are available, a protocol registration can be completed in approximately 17-20 business days, and a results posting can be completed in 25-30 business days. Both of these estimates assume a single round (5 business days) of client review. 

The critical success factors in writing a plain language summary include but are not limited to: 

  • Early identification of number of countries and specific languages required for translation  
  • Utilizing an experienced plain language medical writer AND a developed, well-structured template  
  • Ability to leverage the ICF language (a well-written ICF can save time for plain language summary development) 
  • Early alignment with the appropriate key stakeholders on which outcomes will be presented (e.g., primary and safety only, or primary and key secondary and safety) 
  • Thoughtful application of readability measures/tools 
  • Judicious, complementary use of graphics that contribute to the overall readability and comprehension of the document  
  • Leveraging timelines to produce a shell document early, completing with data once tables, listings, and graphs are available 
  • Agreeing upon (and adhering to) a strategic timeline for stakeholder review 
  • Having a strong project manager assigned to keep the project on track and ensure milestone integrity  
  • Understanding the target audience: incorporation of a structured and well-designed patient review (user test) of the plain language summary to capture end user feedback 
  • Actively implementing and incorporating feedback received from the patient review/user testing 
  • Having a proactive and engaged study team who understands (to some degree) the plain language summary requirements  
  • Setting the expectation that a Master English version will be fully approved by the team before any translations 
  • If translations are required, involving the linguist(s) early on in the project  
  • Wherever possible, centralizing translations 

ProPharma uses an innovative technology platform that leverages AI and automation to identify and redact or de-identify both PPI (Personally Protected Information) and CCI. Our experienced redaction specialists apply a methodical two-step approach to the redaction of each document, to ensure patient and company confidential information are appropriately identified.

Once all content has been identified for redaction, each document undergoes a rigorous quality review to ensure not only the protection of all relevant information but also the consistent application of all applicable standards and regulations (including both industry standards (e.g., TransCelerate) and client-specific guidelines).

Our innovative redaction technology platform:

  • Provides data and document de-identification and anonymization
  • Can redact multiple documents at once
  • Allows for multiple input types (.xpt, .sas, .pdf, etc)
  • Determines risk for re-identification and data utility
  • Auto-generates anonymization reports
  • Allows for re-use by applying the appropriate formatting based on intended audience without the need to re-redact/re-review

Yes. ProPharma's redaction subject matter experts (SMEs) work with clients to develop internal ‘rule sets’ or parameters for the redaction of CCI. We can help guide which functions should be involved in identifying and reviewing for CCI, conduct searches in the public domain to ensure the information labeled as CCI has not already been disclosed, and build a living document that can be deployed across portfolios to increase efficiency.

Throughout the process, ProPharma leverages multiple guidance documents, regulatory drivers, and previous experience including (but not limited to):

  • TransCelerate and/or PhUSE de-identification standards
  • Country-specific guidance (e.g., EMA document-specific guidance)
  • Internal company policies/guidelines
  • Previous health authority feedback and interactions

Yes. ProPharma’s redaction SMEs provide comprehensive health authority interaction support, which includes but is not limited to:

  • Facilitation of meeting setup and delivery
  • Facilitation of EMA review of justification tables
  • Consultation and support of RFIs
  • Work with EMA for CCI review and finalization to avoid rework

Yes! ProPharma can redact site-specific documents in English as well as multiple native EU languages (e.g., German, Italian, French, Dutch, Spanish, etc).

"I am delighted to share this amazing news with you. Results of all 5 clinical studies have been released to ClinicalTrials.gov. An important milestone has been achieved!!! The project was challenging in so many aspects – pressing timelines, high complexity of the studies, multiple competing priorities, and I would like to take the moment to thank ProPharma Group and Kateric team for your hard work, determination, and dedication. It was a pleasure and a privilege working with such fantastic professionals!"

"I am delighted to share this amazing news with you. Results of all 5 clinical studies have been released to ClinicalTrials.gov. An important milestone has been achieved!!! The project was challenging in so many aspects – pressing timelines, high complexity of the studies, multiple competing priorities, and I would like to take the moment to thank ProPharma Group and Kateric team for your hard work, determination, and dedication. It was a pleasure and a privilege working with such fantastic professionals!"

Our Typical Clinical Trials Disclosure Clients Are Those That Need:

People working at a desk

INTERNAL DISCLOSURES DEPARTMENT

Clients with limited internal clinical trials disclosure resources who need to outsource all clinical trials disclosure activities

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AUTHOR SUPPORT

Clients who need to outsource individual clinical trials disclosure components as an augment to existing internal clinical trials disclosure resources

Professional business people working at conference desk

SHORT-TERM AD-HOC SUPPORT

Clients who need to outsource individual clinical trials disclosure components in support of an individual project

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October 14, 2021

Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons

Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

Case Study EU Medical Device Regulation PMO and Project Delivery  - ProPharma

October 14, 2021

EU Medical Device Regulation PMO and Project Delivery

Regardless of your internal resources, it could be extremely taxing and unrealistic to expect your team to accomplish both their normal daily activities as well as the work necessary to ensure...

Case Study Growing a Culture of Quality and Compliance - ProPharma

November 2, 2021

Growing a Culture of Quality and Compliance

One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or...

Case Study How a Two-Part NDA Regulatory Strategy Resulted in Submission Success - ProPharma

September 28, 2023

How a Two-Part NDA Regulatory Strategy Resulted in Submission Success

Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

Case Study How to Ensure Your Multi-Million Dollar Software Launches on Time - ProPharma

October 14, 2021

How to Ensure Your Multi-Million Dollar Software Launches on Time

Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Implementing a technology solution of this...

Case Study How to Manage a Drug Product in a Medical Device Environment - ProPharma

June 1, 2022

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...

Case Study How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach - ProPharma

October 4, 2021

How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach

A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

Case Study How to Successfully Launch Products with QMS and QP Certification - ProPharma

October 14, 2021

How to Successfully Launch Products with QMS and QP Certification

Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...

Case Study Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline - ProPharma

October 14, 2021

Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline

Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

Case Study Increased Visibility for Senior Management with Custom PMO Design, Implementation - ProPharma

October 4, 2021

Increased Visibility for Senior Management with Custom PMO Design, Implementation

Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

Case Study Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days - ProPharma

October 14, 2021

Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days

In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

Case Study Laboratory Informatics with Robotics - ProPharma

October 4, 2021

Laboratory Informatics with Robotics

Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), instruments, and robotics are immensely complex and...

Case Study Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance - ProPharma

October 14, 2021

Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance

When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their...

Case Study Managing Complex Pharmaceutical Projects - ProPharma

October 4, 2021

Managing Complex Pharmaceutical Projects

There are many obstacles your team may face during product development. One of the hurdles includes project management struggles associated with having too many decision makers. Although it is one...

Case Study MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction - ProPharma

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

Case Study Navigating QMS Requirements from a Medical Device Perspective - ProPharma

April 12, 2022

Navigating QMS Requirements from a Medical Device Perspective

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...

Videos Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life - ProPharma

September 28, 2023

Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life

In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

Case Study Overworked Medical Device Teams Missing Deadlines - ProPharma

October 14, 2021

Overworked Medical Device Teams Missing Deadlines

Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma Group’s team can help. You may recognize that this is happening but not...

Videos Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective - ProPharma

May 19, 2022

Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective

As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

Case Study Program and Project Management Effectively Deliver a QMS Optimization Program - ProPharma

April 25, 2022

Program and Project Management Effectively Deliver a QMS Optimization Program

Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...

Videos Insider Talks - To Decentralize or Not to Decentralize … That is the Question - ProPharma

March 25, 2022

Insider Talks - To Decentralize or Not to Decentralize … That is the Question

Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

Case Study Reduced Burden for Oncology Patients With Decentralized Visits - ProPharma

March 21, 2022

Reduced Burden for Oncology Patients With Decentralized Visits

Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....

Videos AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

February 4, 2022

AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!

Case Study Secure Timely Product Launch by Ensuring GDP Compliance Across Europe - ProPharma

October 14, 2021

Secure Timely Product Launch by Ensuring GDP Compliance Across Europe

Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

Case Study Sponsor Successfully Completes Acquisition After Efficient PMA Submission - ProPharma

July 26, 2022

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how...

Case Study Statistical Analytics with Machine Learning Tool Enablement - ProPharma

October 14, 2021

Statistical Analytics with Machine Learning Tool Enablement

Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...

Videos 20 Years of Improving Patient Health and Safety - ProPharma

January 25, 2022

20 Years of Improving Patient Health and Safety

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Case Study Supporting Decentralized Gene Therapy Visits - ProPharma

February 17, 2022

Supporting Decentralized Gene Therapy Visits

Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study....

Videos Cohort Management Process and Planning: Challenges, Risks, and Mitigations - ProPharma

December 7, 2021

Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.

Videos Expedited Programs Explained: How to Expedite Product Approval in the US and Europe - ProPharma

November 12, 2021

Expedited Programs Explained: How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!

Case Study Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors - ProPharma

October 14, 2021

Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors

Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

Videos What Does it Take to Build a Legacy? (20th Anniversary Video) - ProPharma

October 15, 2021

What Does it Take to Build a Legacy? (20th Anniversary Video)

Case Study Understanding Clinical Trial Requirements for Medical Device Label Extensions - ProPharma

October 14, 2021

Understanding Clinical Trial Requirements for Medical Device Label Extensions

After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

Case Study Using Science to Achieve EMA Approval for a First-in-Class Indication - ProPharma

October 14, 2021

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.

Case Study When a Team Lacks Industry Experience - ProPharma

October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

June 16, 2023

Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC

Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

September 28, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

September 28, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

September 28, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands

June 12, 2023

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Flyers Functional Service Provider (FSP) Value Proposition

June 21, 2023

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Flyers Labeling Development & Intelligence

June 21, 2023

Labeling Development & Intelligence

Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses

June 27, 2023

Enhancing Site Capacity for Clinical Trials with DCT Nurses

Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...

Whitepapers Compliance Auditing: Diving into Common Critical Findings

July 31, 2023

Compliance Auditing: Diving into Common Critical Findings

Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...

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