Newsletter | January 2, 2025

01.02.25 -- Easy Mistakes To Make During An FDA Inspection

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OUTSOURCING MODELS

Are You Afraid Of Adopting New Outsourcing Models?

From The Editor | By Dan Schell, chief editor, Clinical Leader

Pricing strategies for outsourcing clinical services have evolved over the years, yet many sponsors are reluctant to change from their status quo. That may change, though, as CROs begin to add technology and site networks to their offerings. 

Choosing A Digital Health Sensor Partner In Clinical Trials

e-book | AliveCor BioPharma

Explore what your organization should consider when selecting a digital health partner and monitoring solutions for your clinical trial.

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

Article | PCI Pharma 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.

Support For Early-Stage Biotech Companies To Secure Funding

Article | Avance Clinical

By combining strategic foresight, operational efficiency, and financial incentives, Avance Clinical empowers biotech companies to navigate funding challenges and bring innovative therapies to market.

REGULATORY & COMPLIANCE

Easy Mistakes To Make During An FDA Inspection

From The Editor | By Dan Schell, chief editor, Clinical Leader

As a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator.

Regulatory CMC Roadmaps

Webinar | Halloran Consulting

This presentation guides viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.

Improving Collaboration And Accelerating Clinical Research

e-book | Advarra

This survey explores how the complexity of clinical research has increasingly challenged the dynamics among research sites, sponsors, and contract research organizations (CROs).

Phase IIb Trial Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer

Case Study | Novotech

This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.

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  • 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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