Newsletter | July 25, 2024

07.25.24 -- What Key Elements Are Lacking In FDA's Latest Diversity Guidance?

SPONSOR

7th Annual SCOPE Europe: Summit for Clinical Ops Executives! Held in Barcelona, Spain, at the InterContinental Barcelona (Fira Center), this event offers three days packed with insights, new case studies, and networking. With six conferences, including two new ones, attendees will explore the latest trends in clinical trial innovation, planning, and operations. For more information visit: www.scopesummiteurope.com.

OUTSOURCING MODELS

You’ve Selected Your Vendor(s), But Have You Considered Their Oversight?

Vendor management has become an even more complex task involving multiple stakeholders, and it may often be overlooked, especially in the oversight of subcontracted vendors.

Unlocking The Secret To Repeatable, Scalable Low Turnover

Explore the evolution of a remarkable 10-year partnership and extrapolate the key principles that create highly cohesive teams and effectively minimize employee turnover.

Enhancing Sterility: The Crucial Role Of Isolators In Sterile Fill-Finish

Isolators provide a controlled and sterile environment during manufacturing. A CDMO that prioritizes quality, sterility, and compliance can help you deliver the highest level of quality and sterility.

Proof-Of-Concept Study Enabled To Drive Novel Gene Therapy Program

Unearth how a natural history trial aimed at addressing the exceptionally rare neurological disease affecting pediatric patients with no existing treatment options was executed successfully.

Site Management Organization: A Detailed Overview

Delve into the transformative power of clinical excellence with Acrostar's SMO Division, a specialized unit operating under the esteemed umbrella of Novotech.

Clinical Intelligence For CROs

Discover how TA Scan, a business intelligence solution, combines and connects global trial, presentation, and publication data to improve RFP support, bid defenses, and operationalization.

SPONSOR

Patient recruitment and retention is a multi-faceted, critical component of clinical trial success. Diversity, timeliness, enrollment, reimbursement, logistics, engagement – where do you start? On August 7th, hear from industry-leading suppliers ready to answer that question – and help solve your specific recruitment and retention challenges. The Clinical Leader Solutions Expo brings you its latest virtual event to help facilitate partnerships that bring life-saving therapies to patients. Register, ask questions, and find your best-fit solution for free.

REGULATORY & COMPLIANCE

What Key Elements Are Lacking In FDA's Latest Diversity Guidance?

The FDA’s new guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies includes several changes, but there are a few key areas where this new guidance falls short.

Ensuring Effective Pharmacovigilance Regulatory Intelligence

Review strategies used by growing numbers of pharma, biotech, and medical device companies for comprehensive and cost-effective PV RI, focusing on key capabilities drug developers should prioritize.

Regulatory Lifecycle Management (LCM) Services

See why managing regulatory compliance for mature products while driving growth through new product development requires careful balance.

Promotional Materials And Compliance Activities

Learn more about comprehensive services for global promotional material review, compliance, and validation tailored to the needs of pharmaceutical and medical device companies.

NDA-Enabling Studies

With 25+ years of experience, our specialists design, conduct, analyze, and report on trials across various therapeutic areas for regulatory submissions.

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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