Full service solution for your disclosure commitments
Clinical data transparency is an integral part of an ongoing effort to improve decisions for everyone involved in healthcare including patients, caregivers, healthcare providers, payers and regulators. The industry faces increasing challenge to develop practical methods to meet growing transparency requirements and compliance.
We are uniquely placed to provide expert, innovative, top quality solutions underpinned by a commercial model to minimise cost.We are the first company to offer end-to-end services in Clinical Trial Disclosure (CTD) (see figure below), bringing strategy and operations consulting, with a formalised full service business process outsourcing proposition for CTD.
Our Clinical Trial Disclosure service portfolio
The Kinapse CTD team actively track and advise clients on the potential impact of key regulatory reforms to align with evolving guidelines and regulations in US and Europe such as the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing, European Union Clinical Trials Regulation, EMA policy for data transparency amongst others.
Kinapse subject matter experts bring experience across a broad range of therapeutic areas, successfully delivering on contracts of all sizes.
To learn more about our Automated Redaction services, open Automated Redaction Service Offering.
For further information on our services in CTD, please contact us at firstname.lastname@example.org