Newsletter | March 27, 2025

03.27.25 -- Mimicking The Hollywood Mindset To Develop Drugs

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Webinar: Inspection Readiness for Decentralized Trials: Lessons from FDA Inspection of Pivotal DCT study

DCTs enhance accessibility by reducing participant burdens like travel and costs. Join us for an overview of a study using DCTs, focusing on the central and local Principal Investigator (PI) roles. Delve into preparations for inspections, including BIMO checklist references, PI interview guidelines, record-keeping requirements, and inspection process details such as agendas, oversight, and follow-up expectations. Click here to learn more.

OUTSOURCING MODELS

Mimicking The Hollywood Mindset To Develop Drugs

Traditional organizational structures often struggle to adapt to the dynamic nature of drug development; consultant Sid Parulkar offers another approach that borrows from the Hollywood film industry.

A Streamlined Approach To 14C Human ADME Studies

Understand the benefits of a program that allows for a flexible approach to human ADME studies and the breadth of supporting data and case studies that demonstrate both significant time and cost savings.

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

How Sponsors Can Leverage New Technologies To Lower Trial Costs

This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.

OneScout: Guiding Patients, Sites, Sponsors, And CROs

From start-up to close-out, Scout helps trials stay on track, patients stick with it, and sites maximize their time and resources.

REGULATORY & COMPLIANCE

Day One Bio's Talks With FDA Help Secure Glioma Drug Approval

Day One CMO Elly Barry, MD recounts the company's experience working with the FDA and turning a passed-over drug into its first-ever approved treatment for pediatric glioma.

Writing Multiple Marketing Applications Simultaneously

A mid-size pharmaceutical company found success in a partnership that aided them in completing medical writing marketing applications on an accelerated timeline.

Debunking Myths And Uncovering The Truths About Quality

Explore this discussion about the myths and misconceptions surrounding quality and compliance.

Understanding Safety Tactics, Regulatory Considerations In JAPAC

As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance.

Drug Development Experience For Biotechs

Leverage our extensive expertise across over 120 therapeutic indications to drive your success.

Get The Facts: NDA-Enabling Studies

Need help with inclusion/exclusion criteria for your Phase 2/3 protocol or an unexpected FDA post-marketing amendment? Altasciences offers reliable solutions with a quick start-up.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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