Regulatory Solutions
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eISF: Industry Standard eRegulatory Software For Clinical Sites
10/6/2023
Modernize your study binder processes with Florence eBinders™, offering remote access for sponsor interactions, monitoring, and source data review.
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Selecting And Evaluating An eRegulatory Solution
10/6/2023
Take advantage of this checklist for evaluating eRegulatory solutions for clinical trial offices.
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Think Canada: The Team Behind Your Clinical Trials
9/29/2023
Altasciences has a bioanalytical and clinical facility in Canada. In this video, we unveil the advantages of conducting trials in Canada while introducing some of the faces that work behind the scenes on your studies.
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Preparing Regulatory Marketing Applications For Successful Conclusions
9/27/2023
Preparing regulatory marketing applications to their successful conclusions is our focus.
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GMP Auditing, Compliance, And Specialized Consulting
9/26/2023
Ready to make your research altogether better? Learn how Advarra® is assisting clients to reduce risk and ensure adherence to good manufacturing practice (GMP), good laboratory practice (GLP), and good tissue practice (GTP) standards.
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Clinical Quality Assurance And Compliance Oversight
9/26/2023
Explore this tailored assessment and support offerings in clinical quality assurance (CQA) compliance, designed to safeguard adherence to relevant regulations and good clinical practice (GCP).
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Making The Impossible Possible In Oncology And Hematology Clinical Development
9/20/2023
When the complexities of designing and executing cancer trials in a highly competitive market can mean delays in delivering urgently needed treatments to patients, it pays to have a trusted partner by your side.
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Get Phase-Appropriate CMC Support
9/20/2023
Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.
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How To Achieve Timely Migration Of Your TMF
9/18/2023
This precise, proven methodology delivers a high-quality migration of your Trial Master File to the destination system, typically just 4-6 weeks after receiving all documents from the source system.
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FDA & ex-U.S. Product Approval
8/2/2023
Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.