Clinical Trial Disclosure

-Collaborate to Innovate Exceptional Outcomes in Clinical Trial Disclosure and Data Transparency
-Expertise | Innovation | Quality | Collaboration | Technology Driven
-The Market leader in clinical trial disclosure services

Year-on-year life sciences organisations are being required to make publicly available more clinical research information and data. Trial sponsors often struggle to keep track of these evolving regulations and choose to outsource this work. For over a decade, Kinapse has continuously evolved Clinical Trial Disclosure (CTD) services allowing our clients to keep pace with – or even get a step ahead of – regulatory requirements.

Kinapse offers a full suite of end-to-end CTD services. We can provide advice on requirements, build solutions and deliver operational activities. From protocol registration through to results posting, preparation of plain language summaries (PLSs), and redaction and anonymization of documents and datasets, we have your clinical and regulatory teams covered.

Kinapse has:

  • ‘FIRST TIME RIGHT’ quality focus (≥80% of deliverables pass NIH review at first draft stage)

  • Achieved 100% timeline compliance for over 15,000 Trial Disclosure deliverables

  • An integrated and customisable platform for automated assessment, tracking and workflow management of trial disclosure deliverables

  • Cost effective solutions for all your disclosure requirements

  • Extensive therapeutic area experience

  • High client satisfaction

  • Efficiency saving

  • Experienced working with regulators

Market leader in disclosure services: Disclosure services have been a central part of Kinapse business strategy for over a decade and we currently support over 50 customers in this area, including many leading global pharmaceutical companies. Our teams advise clients on the specific disclosure requirements for each study and prepare quality deliverables that are compliant to regulatory timelines.

Kinapse Global Disclosure Intelligence: Kinapse supports country-level disclosure intelligence and compliance. Currently we provide advice for global registry requirements for more than 30 countries. This is applied to analyze the disclosure requirements for each study (mandatory vs. voluntary posting requirements), and to understand the implications of non-compliance. This repository is continuously updated as regulatory disclosure requirements change.

Our team brings a wealth of experience advising clients and delivering services related to:

  • The potential impact of key regulatory reforms

  • Aligning evolving guidelines and regulations with internal practice

  • Registering protocols

  • Defining and posting basic results

  • De-identifying and masking data

  • Managing disclosure projects – interfacing with study teams, resolving NIH queries and maintaining posted trials

  • Authoring plain (lay) language summaries

Introducing disclosure360 System and Services Platform

Our automated disclosure360 service platform help clients to efficiently navigate complex global regulatory reporting rules and submission challenges. It supports management of the entire disclosure process, including registry assessments, validation and quality checks, review cycles, approvals, and comments from regulatory authorities. It includes a robust audit trail through compliance reports and performance metrics. This flexible platform augments regulatory intelligence for over 30 registries (including ClinicalTrials.gov and EudraCT) with internal business processes and custom registries.

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Multiple Registries Supported from a Core Dataset: With this platform information can be prepared for submission to ClinicalTrials.gov, EudraCT, or any other global trial registry from a single data record. This allows you to update information once, and your disclosure reporting around the world will reflect that change.

Registry Compliance: Built-in validation rules that mirror registry alerts will ensure your data is accepted by all applicable registries.

Customisable Workflows: Monitor complex international disclosures against pre-set milestones to ensure your studies remain on track and in compliance.

System Integration Platform: Seamlessly pull data from your Clinical Trial Management System and other sources, eliminating the risk of data entry errors.

Intuitive and Traceable Task Ownership: Manage hand-offs between disclosure leads, study teams, and other responsible parties to ensure all information is obtained in a timely manner.

Flexible Compliance and Operational Dashboards: Generate reports to evaluate compliance risks and identify bottlenecks in operational processes. Robust parameters allow you to assess metrics against your own organisational targets.

Request a FREE DEMO of platform by reaching out at hello@kinapse.com

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Plain Language Summary (PLS)

We strongly believe that science is for everyone and that health research findings should be shared with the wider community.