Newsletter | November 17, 2023

11.17.23 -- Understanding ICH E6(R3) And Advancing Trial Efficiency


Optimizing Autologous Cell Therapy Clinical Trials

The optimism surrounding the future of autologous cell therapy (ACT) is well-founded. Beyond its applications in treating autoimmune diseases, bloodborne cancers, and specific solid tumors, ACT is now under investigation for its potential to support wound healing, burn treatment, and postoperative recovery. Discover the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.


Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency

The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials. Could implementation also improve trial master file (TMF) quality in support of greater efficiency?

The Moral Obligation: Digital Data Capture For Patient-Centric Trials

Life sciences companies are falling short in aiding patients and study participants. Get an overview of what's required to make the switch to DDC solutions and how it benefits clinical trial participants.

How To Reduce Risk And Effort When Migrating A TMF

Utilize this summary of key tips, checklists, and lessons learned to mitigate the risks and efforts associated with migrating a trial master file.

How Historical Data And Controls Improve Clinical Trials

Explore the importance of historical data in clinical trials and the potential benefits it can provide for researchers and healthcare professionals.

A Definitive Guide To Digital Evidence Generation

Obtain a complete understanding of enrollment, screening, consent, and data collection by diving into this introductory handbook on decentralized clinical trials.

Are You Leveraging All Of Your Clinical Data?

To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. Learn how you can better utilize your trial data and achieve greater insights.

Pioneering The Future Of Pharmaceutical Supply Chains

Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.

pci | bridge: Real-Time Supply Chain Information

Unlock an enhanced customer experience through digital transformation by applying real-time visibility into your supply chain using cross-functional workflows and data-driven insights.

Services And Solutions For Biometrics And Data Management

Start getting accurate, high-quality, and timely biostatistics services delivered by this team of biostatisticians and statistical programmers, in addition to statistical planning, analysis, and reporting.

How A Healthcare Map Is Accelerating Trial Recruitment

Speed up trial recruitment with clinical alerts driven by artificial intelligence that identifies patients on the pathway toward a diagnosis or therapy switch.


Powerful Integrations That Connect Everything And Everyone

Discover the ways this integration and automation system is revolutionizing the implementation of studies by establishing connections between systems and stakeholders.

Experience The Halloran Difference

By reviewing this established network of repeat customers and best-in-class partners, unearth how companies have been able to maintain effective interactions with regulatory agencies.

Unlocking Real-World Insights For Transformative Clinical Outcomes

Tap into a diverse, tokenized real-world data set covering over 300 million U.S. lives and utilize longitudinal transaction-level patient data and live test/biomarker results.


Global Pharmacovigilance and Risk Management Strategies Conference

Baltimore Marriott Waterfront | Feb 05, 2024 7:00 AM - Feb 07, 2024 6:00 PM
DIA's Global Pharmacovigilance and Risk Management Strategies Conference is a neutral event developed by regulators and industry experts discussing the updates, opportunities, and challenges alongside fresh problem-solving strategies that matter most to safety professionals. Secure your early bird rate today!


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  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
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  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
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