Newsletter | December 1, 2022

12.01.22 -- A 3-Point Strategy For Training Part-Time GCP Consultants


Welcome to the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & ComplianceUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Regulatory & Compliance
How To Optimize Returns On Plain Language Summaries

The EMA now requires plain language summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

Regulatory Strategy Considerations For Working With The FDA vs. EMA

This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.

Solid Tumors: Asia Pacific Clinical Trial Landscape

A solid tumor arises from an abnormally growing mass of cancer cells in organ systems. Read about why one of the major world regions whose incidence and mortality rates are expected to rise dramatically is Asia.

FDA’s September 2022 NPRMs: What They Mean For Industry

On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). This blog highlights some of the major proposed changes and how they may impact the clinical research community.  

Expert Medical Writing For Your Every Need

Our medical writing experts can help you tailor a complete range of regulatory documents that open doors to the future success of your project.

Webinar: Achieving Adaptive Trial Success With A Unified Data Management And Acquisition Platform

Learn about the challenges of delivering complex adaptive trial designs in the real world, and how a strong partnership between a CRO and technology partner can help address these challenges. We’ll share examples of successful methods of trial adaption regardless of phase, therapeutic area, or geographic location, including how the international COVID-19 multicohort TOGETHER Trial was designed and expanded. Click here to learn more.

Outsourcing Models
A 3-Point Strategy For Training Part-Time GCP Consultants

Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.

Investing In Up-Front Communication For An Effective Relationship

Dive into an excerpt of the CMO360° fall 2022 newsletter featuring insights and guidance from Joseph Arcangelo, cofounder and managing partner of the inSeption Group, about how CMOs can effectively engage with their outsourcing partners.

Trial Sourcing Strategies Of Full-Service Versus Functional Methodologies
The functional service provider (FSP) model has experienced accelerated adoption and increased popularity in recent years, due, in part, to the flexibility and control it affords sponsors when compared to full-service offerings (FSOs).
5 Ways SuiteSuccess For CROs Helps Grow Your Business

Sikich SuiteSuccess for CROs can completely transform the CRO business with resource management and finance. Explore some ways SuiteSuccess for CROs helps you control and build CRO business growth.

The Oracle CRO Growth Initiative

In the world of clinical research, speed, while maintaining quality and safety, is crucial. We recognize CROs are racing to attract and win more sponsor business, so we designed Oracle’s CRO Growth Initiative to include an accelerator.