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.
‘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
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
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
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.
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Regulatory & Scientific Writing
We work with clinical teams to help them successfully deliver high quality protocols, study reports and data on time, to budget and in compliance with regulations.