clinical trials disclosure services
Thousands of Records Posted, >90% without NIH Comments
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.
Clinical Trials Disclosure Services
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
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
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
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
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):
- 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
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.
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 FAQsHow are you successful in the clinical trials disclosure space?
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.
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.
IDENTIFY & REPORT
- Review materials to identify applicable reportable information
- Prepare compliant registry record
ENGAGE
- Early engagement of study team
- Solicit and incorporate study team input, confirming alignment with study details
REVIEW
- Multiple internal reviews for both content and quality
- Subject matter expert reviews to ensure compliance with applicable registry guidelines
FINALIZE
- Obtain final approval
- Upload to registry
INTERNAL DISCLOSURES DEPARTMENT
Clients with limited internal clinical trials disclosure resources who need to outsource all clinical trials disclosure activities
AUTHOR SUPPORT
Clients who need to outsource individual clinical trials disclosure components as an augment to existing internal clinical trials disclosure resources
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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