Newsletter | January 18, 2024

01.18.24 -- When A Rare Disease Partnership Evolves Into A Global Effort

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Real Applications For AI In Clinical Trials

You’re fooling yourself if you think AI isn’t going to impact the clinical trial space. It already is, and our guests at the next Clinical Leader Live will talk about their firsthand experiences — and possible future applications — with AI in everything from protocol design to numerous clinops activities. Reserve your seat today for this interactive discussion happening on January 18th!

OUTSOURCING MODELS

When A Rare Disease Partnership Evolves Into A Global Effort

Marked by a gradual evolution from small, meeting-oriented work to a transformative initiative, the FSHD Society and Fulcrum Therapeutics partnership in rare disease research exemplifies the power of trust and shared commitment.

Top Tips For Taming CRO Turnover

How do you handle CRO employee turnover? Senior VP of people operations and culture, Cathy Gooch, discusses the importance of culture, communication, and connection.

Outsourcing Vendor Red Flag #3: Inaccurate Or Low Bids

A bad feeling in your gut is a firm starting point, but strategies exist to substantiate a bid’s value based on more than the “sniff test.” Explore several courses of action in part three of this series.

The Unique Value Of Integrated Safety Services And Technology

In your search for an integrated safety partner, begin by assessing a vendor’s previous experience and whether their PV knowledge aligns with the needs of your product portfolio.

Ensuring Patient Safety, Data Quality, And Protocol Compliance

See how biopharma, biotech, and med device organizations are getting support through a collection of solutions available in a flexible functional service partnership model to meet their unique needs.

Successful Clinical Research Staffing Solutions

Explore the ways Advarra Consulting Institutional Center of Excellence's specialized research professionals are helping organizations reach their goals for lasting success.

EBP: 5 Key Success Factors For Your Clinical Trials

Learn what sets Kayentis' unified platform for electronic clinical outcome assessments and decentralized clinical trials apart from others in the life sciences industry.

SMART First Human Dose (FHD)

A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.

SPONSOR

2024 PDA Annual Meeting

The 2024 PDA Annual Meeting promises to be nothing short of epic! Get ready for plenary speakers who will ignite your imagination, technical presentations, and high-energy roundtable discussions to keep you at the top of the industry, as well as networking opportunities to connect you with the best minds in pharma! Top that off with industry site visits and fun and engaging social activities! Register now.

REGULATORY & COMPLIANCE

Creating Quality By Committing To Compliance In Clinical Research

Discover why a front-loaded investment in compliance can be instrumental in sustaining the integrity of the research process, ensuring optimal clinical trial operations, and safeguarding patient well-being.

Drug Review Profiles: A Deep Dive Into New Drug Approvals

Unearth the dynamics behind interesting and sometimes precedent-setting new drug approvals and uncover how the regulatory process works in practice.

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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