INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • When Other CROs Said No, We Said Yes — To The Nearly Impossible

    The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

  • 2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs and Biologics

    In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).

  • 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

  • Current Challenges (And Solutions) In Global Regulatory Harmonization

    According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. Larger harmonization agreement efforts, even with intervention by the World Health Organization (WHO), ended many times when country regulators bickered over who had the power to develop the standards and whose standards should be followed. The ICMRA, ICH, and other affiliated harmonization groups are acting to correct this.

  • Are You Really Ready For Your End Of Phase 2 (EOP2) Meeting?

    The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission.

  • Taking The Fear Out Of Software Implementation

    Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.

  • Guidance For Remote Monitoring For Sponsors And CROs

    Guidance for implementing remote monitoring as a broad policy at the site level. In light of COVID-19, Veeva proposes that sites and sponsors take a risk-based approach to updating policies and study documents to include only critical elements needed in order to implement remote monitoring quickly while not introducing administrative burden on teams.

  • ICH GCP E6 (R2): A Primer For Small Biotech And Specialty Pharma Companies

    With recent updates to the ICH Good Clinical Practice guidelines biotech and specialty pharma innovators face even greater sponsor responsibilities, the most significant of which may be design and development of Clinical Quality Management Systems to achieve compliance with the revised guidelines. In this white paper, we will explore the revised guideline and discuss its impact on small biotech and specialty pharma sponsors, with a focus on risk-based approaches to quality management.

  • Small But Growing Biotech Manages Disclosure, Maintains Compliance, And Keeps Its Promise To Patients

    For this biotech, the big challenge was both a lack of expertise and resources needed to manage registration of trials and posting results. TrialScope provided a proven solution that optimizes the efficiency of disclosure activities, maximizes trial data transparency, and fosters more informed, engaged patients through open research sharing.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Pharmacovigilance System Master File

    One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.

  • TrialScope Transparency Management Brochure

    TrialScope Clinical Trial Transparency Service (CTTS) enables clinical trial sponsors to engage with patients and the public via a user-friendly, high impact website to openly share clinical trial information and results, demonstrating leadership in transparency while optimizing trial recruitment and retention.

  • Rendering Clinical Research Pandemic-Proof

    The ongoing pandemic is clearly, immediately, and drastically changing the way clinical research is being conducted. A leading eRegulatory solution for high-performing clinical research sites, Complion has remained focused on site regulatory document management while enhancing its solutions for sponsors and monitors involved in that process and responsible for the final submission.

  • DIA Now Frequently Asked Questions

    The DIA NOW Knowledge Service is your trusted source for the latest trends and up-to-the-minute updates on a wide variety of topics from across the healthcare continuum. With access to recorded sessions drawn from DIA’s more than 60 annual meetings taking place around the world, augmented with breaking news and analyses from DIA’s renowned publishing group, DIA NOW is your go-to resource for staying abreast of your field.

  • Regulatory Submissions Regulatory submissions are the most critical milestones in your clinical research program. Quality submissions can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life.