Clinical Trial Disclosure
We are proud to be the market leader in making clinical trial information publicly available. Over the last 10 years we have completed over 10,000 trial transparency deliverables with leading Pharmaceutical clients.
Year-on-year, regulatory requirements are pushing Life Sciences organisations to disclose more and more details of their Clinical Trial results. We understand the on-going struggle to keep track of evolving regulations. That’s why we continuously evolve our Clinical Trial Disclosure services to allow our clients to keep pace with – or even get a step ahead of – regulatory requirements.
Kinapse offers end-to-end Clinical Trial Disclosure services. Depending on your organisation’s needs, we can provide advice on requirements, build our recommended capability solutions and then support delivery of any required activities. From protocol registration through to results posting, we’ve got your clinical team covered.
Currently, the regulatory demands our industry faces are only increasing. For instance, the recent EMA Policy 0070 is forcing our clients to manually anonymize and publish clinical reports. In support of this, we have developed our redact360 service, which combines our deep trial transparency expertise and an innovative technology for the redaction, anonymisation and risk assessment of clinical documents for public disclosure.
Our team have 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.
Explore more of our Clinical services
It is in the clinical space that we do some of our best work and we are proud of the strength, depth and capability of our team to deliver successful clinical advancements.
Clinical Regulatory 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.
Using our industry-leading market access and HEOR services, we help our clients demonstrate the value of the new drugs they have developed.