Newsletter | February 27, 2025

02.27.25 -- Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars

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OUTSOURCING MODELS

Site Capabilities — The Hidden Drivers Of Clinical Trial Success

Guest Column | By Chintan Desai, Stryde Research

We've overcomplicated site selection, says Stryde Research CEO Chintan Desai. Here, Desai details what qualities sponsors should really look for in sites and why some of our existing criteria aren't cutting it.

Considerations When Developing Modified Release Dosage Forms

Webinar | Quotient Sciences

Explore case studies to describe the specialized formulation technologies that are available in the “toolbox” to achieve an optimal target product profile.

Muscular Dystrophy: Multi-National And Multi-Site Trials

Case Study | Novotech

Learn about the success ReveraGen found when expanding their partnership with Novotech to a larger phase 2b trial (VBP15-004) in Duchenne Muscular Dystrophy (DMD).

Bioanalysis Solutions

Brochure | SGS

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Utilize Proven Expertise With Global Solutions For US Biotechs

Product | Avance Clinical

The success of a biotech drug development program often depends on the relationship it forms with its Clinical Research Organization (CRO) partner.

REGULATORY & COMPLIANCE

Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars

Guest Column | By Joseph Pategou

With a projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.

Successful Regulatory Submission Via The Trifecta Of Awesomeness

Article | inSeption Group

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

FDA's Vision On PRO Collection For RWE

Webinar | Castor

In this presentation, a distinguished panel of experts illuminates the crucial role of PROs in shaping regulatory decisions and drug development strategies, particularly in light of FDA expectations.

Proving The Return On Investment For eRegulatory

White Paper | Florence Healthcare

Discover how to optimize clinical trial operations and maximize ROI with this free guide designed for clinical trial professionals and decision-makers with this comprehensive resource.

Prepare Regulatory Marketing Applications For Successful Conclusions

Product | Veristat, Inc.

Preparing regulatory marketing applications to their successful conclusions is our focus.

Regulatory Consultancy Services

Product | Ergomed Clinical Research

These regulatory consultancy services are guided by a team of seasoned consultants, dedicated to developing a proactive and flexible solution tailored to your project’s unique needs.

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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