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.

Clinical Trial Disclosure services from Kinapse

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.

  • 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 redact360

Complying with the new EMA 0070 regulation is time consuming and costly; redact360 is our solution. It’s a unique service that allows clients to automate the redaction of clinical trial documents and meet regulations without wasting employee time. redact360 is a technology-enabled service, backed by the quality checks of our expert Clinical team.

We’ve already used redact360 to deliver 19 successful client submissions and saved clients in excess of £1.4 million.

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