Newsletter | July 11, 2024

07.11.24 -- Getting A Grasp On CRO Selection

SPONSOR

The Sponsor's Clinical Development Handbook For Gene Therapy Clinical Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Its unique pace, structure, and funding dynamics present distinct challenges. Discover essential insights and strategies for overcoming gene therapy development challenges.

OUTSOURCING MODELS

Getting A Grasp On CRO Selection

Companies can spend a great deal of time negotiating preferred provider agreements (PPAs), and their presence, or lack thereof, can make or break which CROs are shortlisted or awarded a Phase 2/3 study.

PV Solutions Optimizing End-To-End Safety In Clinical Development

Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.

Flipping The Drug Development Industry On Its Head

Here, we dive into the obstacles of the traditional outsourcing relationship between CROs and sponsors, and how Altasciences has broken from tradition to offer an alternative model.

Reducing Time To First-In-Human Trials With Robotic SFF Services

Discover how robotic gloveless isolator sterile fill/finish (SFF) systems can accelerate early-phase drug development, ensuring enhanced sterility and streamlined processes for biopharma innovation.

Unlock Additional Capabilities For Your Next Clinical Trial

Gain insight on how a single point of entry can improve patient and site experience by offering best-in-class eCOA, consent management, and patient engagement solutions.

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.

REQULATORY & COMPLIANCE

Is Your Intellectual Property Safe With Indian CROs And CDMOs?

Startups and Big Pharma are considering India as an alternative to China. Is it safe to do business there? Let's explore, with insights from American and Indian attorneys.

Bridging The Gap: Breaking APAC Into The U.S. FDA Market

For APAC companies, it's important to identify the differences in care standards, formulate strategies for compliance, and develop solutions to bridge the regulatory gap and realize FDA approval.

Navigating Local Considerations In Developing sIRB Reliance Policies

Review the importance of training and educating research staff on the sIRB process, fostering a culture of collaboration, and developing mechanisms for monitoring compliance and managing conflicts.

Plain Language Summaries Becoming A Mandate Worldwide

Why the growing global mandates for plain-language clinical trial protocol and results disclosures should influence initial document authoring to reduce redaction and anonymization needs.

A Clearer Harmony And Attractiveness For EU Clinical Trials Regulation

Get the latest insights on navigating the transition to the EU Clinical Trials Regulation (EU CTR) and ensuring alignment across stakeholders for seamless adaptation in this Pharmaphorum podcast.

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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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