clinical research solutions

A global team of trusted experts for multi-phase clinical development.

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Leading Clinical Research Organization

Our team of clinical research experts brings depth and breadth of experience across all phases of clinical trials, applying proven techniques to provide innovative solutions. Regardless of where you are in the product lifecycle or what your clinical trial–related needs are, we offer clinical research solutions to efficiently bring your product to market. With decades of industry experience, our team of clinical research experts is current with the latest industry intelligence and ever-evolving regulations, making ProPharma the partner of choice when outsourcing your clinical trials.

All Clinical Research Solutions:

Our clinical research experts offer solutions to bring your product to market, regardless of where you are in your product’s lifecycle.

 

Full-Service CRO

The path to project success begins with choosing the right model and methodology to anticipate and manage the challenges that could arise during the lifecycle of a clinical trial. In response to more stringent regulations, globalization, and ever-changing technologies, ProPharma can build and tailor the optimal operational model to support consistent quality delivery and maximize participant recruitment and retention while expanding access to diverse populations. We will work with you to develop strategic, flexible approaches that leverage technology, clinical informatics, and our global reach to maximize data‑driven decision making that drives safety, quality, and efficiency.

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Clinical Operations Services

Clinical operations play a pivotal role in the successful execution of clinical research, encompassing the design, implementation, and management of Phase I to IV trials.

With the increasing complexity of clinical trials, driven by heightened regulatory guidelines, the pressure on clinical operations teams has intensified. While some organizations allocate considerable time and resources to this aspect, others opt to outsource their clinical trials to Contract Research Organizations (CROs) specializing in the specific field of research. These CROs offer comprehensive services, ensuring end-to-end support for the seamless execution of trials.

Our dedicated clinical operations team collaborates with you to optimize the design of your clinical trials, implement patient-centric approaches, and provide guidance throughout the entire clinical development lifecycle. Discover how our experts can assist you in the multi-phase development of your clinical operations.

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Two women technicians using a laptop in a laboratory.

Global Clinical Trial Management Teams

Global footprint, local expertise: we provide the flexibility you need in a rapidly evolving environment. Our experienced teams offer the footprint to meet your local clinical trial needs, with the confidence and agility to globalize when you are ready. Our global governance structure streamlines the complexity of multi-region studies.

Data Safety Monitoring Board

Data Safety Monitoring Board (DSMB) services provide you with improved workflows, compliance, and communication to ensure the safety and integrity of your clinical study data.

PhoPharma’s team of medical consultants provide the option of safety data review (i.e., individual case safety reports and/or aggregate summaries of data) by a physician with experience in pharmacovigilance. The review and consultation include an assessment of the data and its significance to the conduct of the study. Our team then provides a recommendation for any actions to be taken, including reporting of aggregate data to the FDA as an IND Safety Report, requesting review by the DSMB, and/or changes to the Investigator's Brochure, Informed Consent Form, or study protocol.

ProPharma's DSMB, medical monitoring, and physician teams support a wide variety of therapeutic areas and will meet your requirements and keep your study moving forward by providing any or all of the following services:

  • DSMB program support
  • Blinded and unblinded DSMB meeting support
  • Eligibility requirements review for inclusion/exclusion criteria issues
  • Protocol review for exemptions and deviations
  • Medical crisis impact review involving a study patient
  • Biostatistician review
  • Laboratory findings review
  • Reporting a serious adverse event (SAE)
  • Causality assessment discussions
  • Clinical Trial Emergency Unblinding Services

Medical Monitoring Services

At ProPharma, our medical monitoring consultants will work with you to ensure safety and compliance throughout your clinical trials, from pre-trial planning through end-of-trial review.

Our team of physicians can evaluate your medical monitoring system to ensure there are no pharmacovigilance medical monitoring bandwidth issues, and partner with you to ensure you have the right resources to keep your clinical trials on schedule.

We will help you meet requirements to maintain quality and compliance throughout your clinical trials. Our medical monitors have vast knowledge in a wide variety of therapeutic areas and partner with you to address all your needs, including:

  • Inclusion/exclusion criteria issues
  • Protocol exemptions and deviations
  • Medical crisis monitoring for cases involving a study patient
  • Medication issues
  • Laboratory findings
  • SAE reporting
  • Causality assessment discussions

Contact us to learn more about our medical monitoring services and how we can provide expert guidance for your upcoming clinical trials.

Talk to an Expert

Clinical Trials for Pharmaceuticals, Biologics, Medical Devices, and Diagnostics

With dedicated pharmaceutical, medical device, and diagnostics teams, ProPharma supports clinical trials in the most cutting-edge technologies, maintaining expertise in novel uses of less novel therapeutics, and repurposing products. We have internal SMEs including a Biologics Center of Excellence and create solutions to complex challenges.

Expertise Across All Study Phases and Therapeutic Areas / Specialties

Our teams work together to take you all the way through the development lifespan, from early pilot studies dose-ranging studies through pivotal registration studies. We focus on the patients, providing consistent delivery of the quality data you need.

Deep Functional Expertise

ProPharma’s Medical Writing teams create best-in-class quality documents to support all elements of your clinical trial needs, from protocol and consent forms, Investigator’s Brochures, clinical study reports, patient narratives, and CTD Module documents, to registering and disclosing clinical trial information on public registries and redacting documents to meet commercial transparency obligations while protecting patient and company confidentiality.

Our world-class Biostatistics and Data Management teams and programmers are adept at creating and managing quality design, build, and outputs. They will partner with you to ensure you achieve the most robust and successful outcomes, incorporating unique and adaptive designs where best suited.

Global pharmacovigilance specialists and medical monitors are here to support the safe implementation of your studies, and provide expert guidance, reporting, and DSMB management. We have a range of disease and therapy area experts to ensure you have the best, contemporary advice.

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Functional Service Provider (FSP)

Clinical trials can be a costly drain on time and resources. Working with a quality FSP allows you to save on cost when outsourcing specific clinical services. This enables the project to reach completion faster while improving the overall quality of the work and driving efficiencies. As part of our FSP model, we provide functional expertise, resource management, and innovative solutions that are customized to meet the specific needs of our clients.

ProPharma offers a range of FSP models to fit all requirements, providing specific therapeutic area expertise, operational expertise, and integrated processes and systems, to ensure we map the right outsourcing approach to fit your project. We help our clients develop solutions that span clinical operations and clinical data sciences, as well as safety, nonclinical, and regulatory writing.

ProPharma provides all levels of support ranging from deploying a small group of experts within a function to supplementing an entire department of full-time equivalent staff. Our team of experts works as an extension of your team, bringing you immediate scalable resources who will align with your processes and environment. With our collaborative approach, we can provide strategic solutions that are built on a foundation of strong partnerships.

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Exceptional Quality

By monitoring key metrics, checking for variations, evaluating enforcement trends, and investing in industry-leading expertise, we become your partner with measurable results. When you work with us, you get a high-caliber team that analyzes your KPIs to optimize your existing operational environment and develops tailor-made solutions that fill the gaps to create exceptional results.

Speed to Global Scale

Our industry-leading experts span across the United States and the Rest of World (ROW) to offer you a scalable network of professionals to execute your most complex and resource-dependent initiatives. ProPharma provides a flexible, dedicated, and global resource team that is scaled to accommodate your individual clinical trial needs.

Therapeutic Expertise

Our team consists of SMEs with varied backgrounds across the pharmaceutical, biotechnology, medical device, and diagnostic industries. With our deep-rooted expertise across countless therapeutic areas, we can anticipate obstacles and develop a strategy that fits our clients’ unique needs. Having a top-tier team of professionals allows our FSP infrastructure to move resources internally across clinical programs.

100% Dedicated Teams

We don’t just offer solutions; we tailor them to your needs with experts who are experienced across all phases of clinical development. At ProPharma, we know that a successful compound starts with the right team, and we’ll build it with you. Our FSP model is a Win-Win Functional solution because it fosters a partnership that brings together shared expertise & industry experience.

Time and Cost Efficiencies

The FSP model offers significant reduction in costs with greater potential to drive operational efficiencies over time. We enable companies to grow in infrastructure without the headcount burden & risks associated with HR costs & processes. Let ProPharma manage the administrative burden, so you can concentrate on the core tasks of the clinical trial, ensuring business continuity and driving efficiencies.

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Decentralized Clinical Trials

Decentralized Clinical Trials (DCTs) are studies that are designed for study visits, procedures, and data collection to occur outside of the traditional site setting. DCTs revolve around the concept of patient centricity, with the goal of making participation easier and more convenient for the patient, ultimately creating a larger, more diverse population to test your drug or device while ensuring patient comfort and safety. The increased flexibility of DCTs expands the geographical reach, improves recruitment and retention, and enhances the patient experience while providing Sponsors with reliable data.

We support DCTs by providing the opportunity for study visits to take place in a location convenient to the patient, such as their home or office, supported by our team of employee GoClinical Clinicians who are trained in GCP and protocol-specific procedures. 

Home Visits

It can be overwhelming to determine how to deploy a decentralized approach, so incorporating home visits into your protocol is often a great place to start. ProPharma can support home visits as part of a hybrid or completely virtual trial design. Home visits allow for greater flexibility in your study design and reduce the burden of participation on the patient by designing processes that fit into the patient’s life, rather than asking the patient to fit their life into the trial. Allowing simple procedures to be performed in the patient’s home, also reduces the burden on the site by allowing site staff to focus on recruiting and enrolling patients and more complex procedures.

Employee Nursing Staff

ProPharma directly employs all GoClinical Clinicians (GCCs) to support your patients. Once hired, all GCCs are overseen by our Director of DCT Nursing and receive extensive training in GCP, IATA (Dangerous Goods), and protocol-specific procedures. This allows us to have direct oversight of all visits and ensures those visits are performed by known, high-quality clinicians with strong clinical skills and trial experience. GCCs are selected based on study requirements and range from phlebotomists, LPNs, and RNs. We are easily able to add GCCs based on location by leveraging extensive Global Talent Acquisition team and sister staffing companies, with over 25,000 qualified providers currently in our global database. Our approach reduces sponsor costs, removes unnecessary layers of vendor administration, and alleviates the challenges of finding providers with short notice through local home health agencies, significantly reducing the risk of missed visits.   

 

employee-nursing-staff

 

Proprietary eSource Technology

GoClinical, our proprietary, 21 CFR Part 11 and GDPR compliant eSource platform allows for the collection of source data from home visits and electronically sends data for entry into the EDC. All source forms are designed per study to mirror the CRF and act as a guide for our GCCs performing home visits. This approach to source collection significantly reduces source turnaround times, reduces documentation errors, and improves PI oversight.

Experience and Global Reach

ProPharma has invested in hiring the best leaders within the Decentralized Clinical Trial (DCT) space to build out the most efficient operational strategy based on lessons learned from several years of past experience. As the decentralized approach grows in the clinical research space, it is becoming even more important for Sponsors to have a reliable partner that can assist in designing trials with decentralized approaches in mind. Our DCT leadership team has over 10 years of experience in the DCT space and can help your team design and implement the right DCT solutions for your trial. Whether you’re interested in hybrid or completely virtual clinical trials, our team of experts can help.

ProPharma has 27 offices worldwide spanning 6 continents, providing a truly global footprint to support your decentralized clinical trials. ProPharma has 20 years of experience supporting Sponsors from early development through commercialization, which allows for expert insight at any phase or function of your study and a streamlined approach from a single provider.

decentralized-clinical-trial-visit-procedures

Decentralized Clinical Trial Visit Procedures

Our decentralized visits include critical procedures for your clinical trial’s success. Let our team of experts review your protocol or draft synopsis and consult with your team on what visits or studies could benefit from a DCT model. Our procedural capabilities are as follows:

 

 

  • Vital Signs and Associated Variables
    • Temperature
    • Respirations
    • Blood Pressure
    • Pulse/Pulse Oximetry
    • Weight/Height/BMI
  • Lab Sample Collection and Processing
    • Blood/Plasma
    • Urine
    • Saliva/Sputum
    • Stool
    • Finger Sticks
  • IP Logistics
  • Targeted Clinical Assessments
  • IP Administration
    • Infusion
    • Injection
    • Oral
    • Topical
  • Telehealth Support
  • Patient-Reported Outcomes and Scales
  • Patient Training
    • IP Administration
    • Diary Completion
    • Device or Wearables
  • Other Safety Assessments
    • Changes in Health Status or Concomitant Medications
    • ECG Collection

Explore Decentralized Clinical Trials

Embedded Solutions

Our team of project leaders and clinical subject matter practitioners can support you in your journey to successfully deliver projects, achieve critical outcomes, and realize or improve efficiencies. Whether you are looking for an expert to provide advisory services or several cross-disciplinary personnel our solutions-focused approach will add value to your organization.

Specialized Project-Based Services

Our team of qualified consultants apply proven and proprietary project management methodologies to help you successfully develop and launch products to market safely and quickly. By focusing on your desired outcomes, we take time to thoroughly plan the solution. We have done these projects before and understand the functional dependencies that can impact the plans and know what works.

In-Depth Expertise

Our team of clinical experts bring leadership to your projects to help you successfully complete your important, complex projects regardless of where your team is in the clinical development process. We help you get to decisions quickly and achieve outcomes.

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Global Medical Writing Transparency

ProPharma strategically partners with clients to provide individualized, single-source, scalable medical writing solutions across the following areas:

  • Medical Writing – Clinical, Nonclinical, Device, Diagnostics, and Publications
  • Quality Control Review and Editing
  • Clinical Trials Disclosure – Document Redaction/Anonymization, Clinical Trial Registry Authoring, Plain Language Authoring, and Management Consultation
  • Project Support – Project Management, Document Publishing, Submission Management, SOP Development/Template Creation

Our global team of medical writers and reviewers have deep domain expertise and autonomously drive projects to completion, collaborating with cross-functional teams to coordinate all aspects of input, production, and review of every document with a laser focus on quality.  Whether you need to outsource all medical writing across several clinical trials or a portfolio of products, or you need project-based support for individual medical writing deliverables, our expertise and experience can be leveraged to build a customized solution that achieves all your project goals. 

Explore Global Medical Writing Transparency

Clinical Research Solutions Experts

Marcy Komocsar

Marcy Komocsar

Senior Vice President
Clinicial Research Solutions

Alena Hammond

Alena Hammond

Global Head
Clinical Operations

marija buchholz headshot

Marija Buchholz

Senior Vice President
Global Clinical Operations

Helen Hall

Helen Hall

Global Head
Clinical Data Sciences

Robert Rachford-2

Robert Rachford

Vice President
Biostatistics and Programming

Mary Culliton

Mary Culliton

Senior Vice President
Global Medical Writing

shelby stillwagon headshot

Shelby Stillwagon

Senior Director
Decentralized Clinical Trials

Kevin Wysocki

Kevin Wysocki

President
Clinical Research Solutions

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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

December 8, 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’s team can help. You may recognize that this is happening but not necessarily know...

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 company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how ProPharma...

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'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 Overview Video  - ProPharma

October 4, 2021

ProPharma 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

December 8, 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

December 8, 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 Services Overview - ProPharma

October 4, 2021

ProPharma Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development from ProPharma

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 - Flyer

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) - Flyer

December 8, 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 eBook

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 - A ProPharma Whitepaper

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 Whitepaer

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 Whitepaper

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

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

eBook Evolving EMEA MI Service Models eBook

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 Whitepaper: 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 eBook

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 eBook

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 Case Study

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 Guide to 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 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 Case Study

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 Flyer

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 Case Study

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 Whitepaper

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...

Case Study Biostatistics and Programming - More than Just Clinical Trials - A ProPharma Case Study

October 16, 2023

Biostatistics and Programming - More than Just Clinical Trials

Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.

Flyers Product Quality Complaint Management - ProPharma

October 19, 2023

Product Quality Complaint Management

Ensuring the safety and health of patients is of utmost significance when it comes to pharmaceuticals, medical devices, and diagnostic programs. This is especially vital in today's intricate and...

Case Study Case Study: Product Quality and Safety Issues with Global Collaboration

November 6, 2023

Tackling Product Quality and Safety Issues through Global Collaboration

See how ProPharma effectively addressed a globally renowned corporation's surge in product quality complaints and financial pressures by establishing a tiered support system, leveraging offshore...

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