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Regulatory Consulting/Support

Providing assistance throughout the development, approval, and post-approval stages of a product's lifecycle.

  • Global Regulatory and Safety Strategy Development Review and Assessment
  • Quality and Regulatory Compliance Audits and Training
  • Identification, Inspection and Due Diligence
  • Reviewing and Assessing Clinical and BE Study Protocols
  • CMC, non-Clinical, Clinical Data Review
  • Gap Analysis
  • Liaison Services with Global Regulatory Agencies
  • Translation of Technical Documents Dossier Management
  • Project Management
Regulatory Consulting/Support

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Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Learn about When EDC is not enough: Automating multi-country data collection and complete workflows at #DIA2019! Ja… https://t.co/zJfytNpz82
Bioclinica (2 days ago)
In San Diego for #DIA2019? Visit us at booth #1831 and meet face to face with our team to learn more about our rapi… https://t.co/T4U4oNXlxo
Bioclinica (2 weeks ago)
We're celebrating International #NASH Day to help raise awareness about non-alcoholic steatohepatitis & fatty liver… https://t.co/16PfGbzeaS
Bioclinica (2 weeks ago)
Global site payments automation in clinical trials. Ck it out! https://t.co/QUEhyRMsN4 https://t.co/pZ0ZUviKuv
Bioclinica (4 weeks ago)
Come talk to #Bioclinica at #ASCO19! See why we're the world leader in #oncology imaging, helping to assess efficac… https://t.co/h0ng6StIbU
Bioclinica (4 weeks ago)
Great insights for sponsors conducting #NAFLD #NASH #clinical trials. https://t.co/TG1WwRhVE8 https://t.co/US2Iobjoyd
Bioclinica (4 weeks ago)

Latest Blogs:

Medical Imaging of Non-Alcoholic Fatty Liver Diseases in Clinical Trials
EDC Provider Selection
Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
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