Newsletter | February 8, 2023

02.08.23 -- A 3-Stage Framework For Decentralized Trial Maturity


Welcome to the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial ManagementUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Trial Management
Implementing Patient-Focused COAs In Trial Design

Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

Considerations When Planning And Conducting Early-Stage Trials

Close cooperation between major global regulatory entities and industry sponsors can help adjust processes to maximize drug development efforts, speed up access to novel therapies, and help control development costs.

Planning Your Packaging For A Seamless Transition From Clinic To Launch

Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.

Tips For Overcoming Today's Drug Supply Challenges Through Technology

Learn how to manage a supply chain through IRT with self-service tools and actionable insights as well as best practices for supply forecasting and overstock management.

Evolution Of Cell And Gene Therapy In China: The Case For Universal CAR T

China now represents 60% of clinical development in CAR-T therapy development globally: what have we learned to date and where are future opportunities?

Are We Ready For A Unified Clinical Platform?

Industry experts from Eli Lilly and Cognizant share their perspectives on the process and building blocks of end-to-end clinical development, the essential elements of a unified clinical platform, and the benefits and challenges involved in realizing the vision of a unified clinical platform.

The Rise Of Radiotherapeutics: Brief History And Best Practices For Clinical Trials

Delve into a brief history of radiopharmaceuticals and discover best practices for planning and executing clinical trials utilizing these novel drugs to treat cancer.

Advarra University And Training

Advarra University is the main hub for the training opportunities to help your team and staff feel confident in navigating the technology in their day-to-day operations.

Real Solutions To Challenges In Clinical Trials For Cell And Gene Therapy

Cmed is highly experienced in the management of cell and gene therapy clinical trials, whether in oncology, rare diseases, or other therapeutic areas.

2023 PDA Annual Meeting
April 3 - 5 | New Orleans, LA

The premier biopharmaceutical manufacturing science and technology meeting is making its way to New Orleans, LA! The program includes a stimulating lineup of industry speakers and carefully curated sessions on topics such as rare diseases, digitization of pharma, and meeting patients' needs. Enjoy plenty of opportunities to network with vendors and colleagues and free time to explore the lively city!

Decentralized Trials
A Three-Stage Framework For Decentralized Trial Maturity

Decentralized clinical trials (DCTs) offer clear benefits to patients and the overall success of the trial, but it can be difficult to know how to address this challenge. This three-stage framework approach will enable you to assess your organization’s current clinical trial innovation maturity and build a plan from there.

Complex DCT Delivery: What Is Possible Outside Of A Site?

Todd McGrath, chief operating officer, and Emily McDougal, executive director nurse management, will show you how a decentralized delivery of complex clinical visits benefits your clinical trials, sites, and patients.

Unraveling Hybrid Clinical Trials: Challenges And Opportunities

Hybrid trials have undergone rapid evolution in the past few years. Examine this evolution, the reasons for confidence and concern, and how they may impact pharmaceutical development in the future.

Direct-To-Patient Supply: Industry Perception And Future Trends

Two hundred thirty-four individuals involved in clinical supply and operations were surveyed to better understand sponsors’ perspectives on DTP distribution of clinical supplies and interest in using it in their studies.

Decentralized Clinical Trials: The Future Of Clinical Research

Our integrated EDC platform, including eConsent, ePRO, RTSM, and DDC, is your gateway to decentralized trials. 

Direct-To-Patient Services

Thermo Fisher Scientific provides scalable, custom, direct-to-patient services that ensure patients receive their medication with controlled and on-time delivery.