INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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![GettyImages-842852944 study]( "Executing A Dual-Submission Study")
Executing A Dual-Submission StudyDual submissions can pose a range of difficulties for clinical trials. Gain insight into how multiple requirements can be addressed successfully with the right strategy.
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![GettyImages-523184134 diagnostics]( "IVDR Survival Guide Part 1: Classification, Clinical Evidence, & Performance Requirements")
IVDR Survival Guide Part 1: Classification, Clinical Evidence, & Performance RequirementsHave common questions concerning the IVDR product classification system addressed and learn how to comply with new clinical evidence and performance expectations.
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![GettyImages-136640925-vial-vaccine]( "Leveraging The Bolar Exemption To Accelerate Market Access")
Leveraging The Bolar Exemption To Accelerate Market AccessGain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.
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![GettyImages-1364024838 lab]( "FDA's Q&A On 21 CFR Part 11 For Clinical Investigations")
FDA's Q&A On 21 CFR Part 11 For Clinical InvestigationsExamine six of the more significant points from the draft guidance, specifically as they pertain to the electronic Trial Master File.
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A Beginner’s Guide To Medicare Coverage Analysis3/14/2023
Learn how a developed billing plan by performing MCA can help individual research sites and sponsors estimate their expenses on protocol-required items and services.
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Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change3/9/2023
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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5 Ways FDORA Will Impact Clinical Research Sponsors3/7/2023
While the FDA Omnibus Reform Act of 202 is slowly changing aspects of clinical research, explore five main ways studies are currently being impacted and what trial teams can do about it.
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FDA Guidance Has Implications For EDC And EHR eSource Capabilities2/28/2023
Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.
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Tips For Working With A Single IRB For The First Time2/23/2023
Ensure the protection of research participants, proper address of local requirements, and a competitive and productive research program with a single institutional review board (sIRB).
CLINICAL TRIAL REGULATORY SOLUTIONS
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![Responding To Regulatory Inspection Observations: Do’s and Don’ts]( "Regulatory Affairs Consulting")
Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.
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![Medical Data iStock-698677764]( "Pharmacovigilance And Safety Surveillance")
Delivering safety surveillance before and after regulatory approval for pre-approval and marketed health products.
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![Aerial View of Business Meeting]( "Marketing Applications For Regulatory Approval")
Preparing regulatory marketing applications to their successful conclusions is our focus.
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![iStock-178131492-lab-research-beaker]( "Institutional Biosafety Committee (IBC) Reviews")
IBC review involves the deliberate transfer of engineered genetic materials to human research subjects. Read our latest brochure on IBC review.
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To mitigate the uncertain clinical trial landscape and make better data-driven decisions, clinical development groups have turned towards real world data (RWD) to augment and inform their understanding of the disease and treatment landscape. Integrated Evidence from Acorn AI provides access to a one of a kind cross-sponsor, regulatory grade, patient-level clinical trial dataset with pre-integrated real world assets to help clinical developers make critical data-driven decisions throughout the product development lifecycle and increase their probability of success.
