Newsletter | September 21, 2023

09.21.23 -- New ICH GCP E6(R3) Draft Guidelines


Webinar: How To Overcome Data Challenges And Experience The Benefits Of DCTs — Guidance For Patients, Sites, And Sponsors

Join us to discover how a data-led approach and innovative intuitive integration tools are resulting in closer connections to patients, consistent data flows, and faster insights. Learn how to transform the way you customize data management activities during collection and curation of data for a DCT clinical trial! Click here to learn more.


What You Need To Know About The New ICH GCP E6(R3) Draft Guidelines

The ICH’s updated draft guidelines for planning, designing, conducting, recording, and reporting clinical trials introduce a dynamic, risk-based approach to trial design and create universal standards for data.

Creating Quality By Committing To Compliance In Life Sciences

Given the diversity in learning preferences, learn why research staff training should encompass various sensory modalities so that everyone involved can understand clearly what has to happen, and how.

Product Expertise And Market Knowledge Secures Fast-Track Review

Unearth how an international company was able to realize the full potential of its product by combining product expertise with target market knowledge to create a winning strategy.

5 Steps To Overcome Barriers To eRegulatory Adoption

Gain insight from this collection of best practices when transitioning from traditional paper and fragmented technology workflows to a fully electronic and purpose-built eRegulatory platform.

Biotech, Pharma Embrace Regulatory Technology Outsourcing

Managing risks, time, effort, and costs while meeting regulatory demands can be overwhelming. Discover how blending human expertise with technology can increase efficiencies and reduce error.

How Recent Regulations Are Helping Advance eCOA And ePRO

Consider new perspectives on 2023-issued guidance by the EMA and FDA, and how the amalgamation of these directives, combined with scientific insights, can empower sponsors and biotech firms.


Efficient Biotech Vendor Selection And Management During Economic Uncertainty

To navigate these turbulent economic waters effectively, we must view this funding crunch as a push for creativity and resiliency. This present moment requires a strategy integrating savvy financial management and strategic vendor selection to ensure a thriving biotech.

Why CRO Staff Need Robust Digital Literacy Skills

Explore what specific forces are driving the need for strong digital knowledge and how contract research organizations can build those skills for use now and in the future.

Shifting To A Functional, Flexible, And Fractional Workforce

See how one company has redefined the functional service provider model to accommodate demand from both sponsor parties and employees for a more accommodating work environment.

DLBCL Asia-Pacific Insights And Experiences

Get an overview of trends and insights into the current development of DLBCL clinical trials in the APAC region and excerpts from an expert panel discussion with participants from eight APAC countries.

Optimizing Drug Development: 4 Key FSP Considerations

Review several benefits of using a functional service provider model and what four things to consider before choosing a partner to help meet challenging drug development timelines.

Solutions For Sites And Institutions

Streamline workflows across all types of sites, including academic medical centers and commercial sites of varying sizes, with Advarra’s complete suite of independent oversight committees.


Driving On-Time Delivery In Drug Development: How The Implementation Lead Drives Efficiencies In FSP Engagements

Live Online: Wednesday, September 27, 2023, 11:00 a.m. EDT 
Join subject matter expert Cami Stewart-Myers, associate director, project management for PPD FSP solutions, in this upcoming webinar to explore how an implementation lead helps streamline start-up and drive on-time delivery during the critical initial stages of an FSP engagement. Click here to learn more about this webinar and how it will benefit those in biopharmaceutical and biotechnology companies!


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  • Decentralized Trials | Trial Management (Wednesday)
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