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Medical Writing: 

Strategy, Experience and Compliance

The transparency and disclosure of clinical trial data is a requirement in many countries and is crucial to build trust and engage patients, clinicians and the pharmaceutical industry in the development of new treatments. As a result, the pressure for sponsors to disclose data is increasing and there are several regulations in place across the globe with which companies must comply. Still, the regulations, policies and guidelines in this field are a continuously evolving landscape, making compliance one of the greatest challenges for sponsors. 

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At ClaritiDox, our team of consultants has been supporting client compliance since the first regulations were published. With years of experience, we offer a deep understanding of the most up to date global regulatory landscape and are uniquely positioned due to our knowledge of processes across Tier 1 to 3 pharma. In addition, our diverse background, which ranges from nonclinical to clinical research, and breadth of therapeutic area expertise, allows us to effectively support a wide range of sponsor goals.

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When working with our consultants, you can expect the following:

  • Active monitoring of the global regulatory landscape and understanding of its impact

  • Open sharing of their wealth of experience 

  • Expert level experience working with registry reviewers

  • Assessment of your current compliance across global registries

  • Development and implementation of fine-tuning robust, global disclosure programs, including standard operating procedures, style-guides and quality controls

  • Clinical trial registration and disclosure of results in registries such as ClinicalTrials.gov, CTIS/EudraCT, UK, including plain language protocol synopsis and results summaries 

  • Strategic consulting and project management

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