Regulatory Planning & Strategy

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Develop corporate transparency policies to comply with regulations

Our planning and strategy solutions offer support for developing your disclosure Standard Operating Procedures (SOPs) based on compliance best practices developed over 15 years and with the experience of thousands of trials. Our experts will work with you to develop your transparency strategy that meets the regulatory requirements and reflects industry trends.

Regulatory planning and strategy

Get support and expert advice on best practices for clinical trial disclosure

Driven by our experience of working with 16 of the top 20 largest pharmaceutical companies and over 30 small and mid-sized biopharma organizations, Citeline has established a pragmatic approach to developing corporate transparency polices and efficient disclosure processes.

  • Gain insights into the latest clinical trial disclosure trends and strategies
  • Develop your corporate transparency policy to comply with regulations and reflect your approach to data sharing
  • Implement best-practice processes for efficient and inspection-ready disclosure

Relevant Products & Services

Trialscope Atlas
TrialScope Atlas
The what, when, where & why of clinical trial information disclosure. Atlas enables clinical trial sponsors to quickly and accurately provide an answer to the question: Am I compliant? In doing so, Atlas reduces the risk of non-compliance by providing real time access to consolidated, global disclosure compliance performance metrics.
Key Benefits
  • Library of global compliance rules
  • Tailor to match your policies
  • Assess your global compliance performance
Trialscope Disclose
TrialScope Disclose
Accelerated clinical trial disclosure starts here. TrialScope Disclose keeps you ahead of changing regulations and evolving expectations, empowering you to maintain global disclosure compliance from a single, centralized platform.
Key Benefits
  • Improve speed and accuracy of submissions
  • Automate data entry and streamline processes
  • Re-use approved trial data across global registries
Trialscope Intelligence
TrialScope Intelligence
Streamlined clinical trial disclosures. Reduce manual work, leaving your team more time to strategize and plan timely, high-quality and compliant clinical trial disclosures – in the countries that are relevant to you.
Key Benefits
  • Access to country and registry requirements
  • EN-language translations
  • Get direct access to our leading expert analysts
Pink Sheet
Pink Sheet
Since 1939, Citeline’s Pink Sheet has been the leader in providing business-critical insights on pharmaceutical news, and analysis of regulatory policies and trends. Our global team of more than 20 journalists tracks marketing application progress from submission to approval, covering biosimilars, generics, brand name/innovator drugs and more.
Key Benefits
  • Business-critical policy and regulatory insights
  • Exclusive access to trusted analytics and data
  • Global coverage directly from key markets
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