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:

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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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