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 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.

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):

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. 

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.).