Newsletter | March 29, 2024

03.29.24 -- Why Small Clinical-Stage Companies Need Developmental Risk Management Plans


Medical Affairs: Enhance And Expand Your Team’s Impact

In the dynamic landscape of healthcare, medical affairs teams play a pivotal role in connecting pharmaceutical entities, healthcare practitioners, and patients. Explore strategies for overcoming obstacles, harnessing the potential of Big Data and AI, and fostering team empowerment to ensure ethical promotion and make informed strategic choices amidst the industry's rapid evolution.


Why Small Clinical-Stage Companies Need Developmental Risk Management Plans

For small clinical-stage companies, developmental risk management plans are not a regulatory requirement but a strategic imperative to proactively manage risks.

Mitigating CAR Risks In Autologous CAR-T Therapy Trials In Oncology

Consider these practices when managing toxicities associated with autologous Chimeric Antigen Receptor T-cell therapies among patients with B-cell hematologic malignancies.

Simplifying Medical Monitoring With The ClinReview Module

Check out this all-encompassing module that simplifies and automates the medical review process, allowing medical monitors to prioritize the most crucial aspect — patient safety.


EDC has become a premier clinical technology in improving data accuracy and reducing site burden through time and resource conservation. But which EDC do you choose? In this Clinical Leader Solutions Expo: EDC Showcase segment, Brian Dufresne, SVP of Business Development at CDS delves into who CDS is, what they do, how they're different, and how clinical research teams can quickly design, deploy, and manage studies without the need for programming via TrialKit. Watch here.


Making Rare Disease Progress With Novel Strategies, Data Standardization, And More

The integration of innovative research methodologies, coupled with the standardization of data and use of advanced visualization techniques, represents a holistic strategy to address the complexities of rare diseases.

Automation, Innovation, And The Future Of Drug Safety

Bruce Palsulich, vice president of safety solutions at Oracle Life Sciences, discusses how generative AI and automation are working to advance safety and pharmacovigilance.

3 IRT Tactics Being Used To Streamline Supply Logistics

Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.

Connecting Patient-Level Clinical Data To RWD

Discover data linkage: a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data and real world data at the patient level.

Data Management For A Clinical-Stage Cancer Immunotherapy Study

Uncover the results from a clinical first-in-human study evaluating the safety and tolerability of an investigational cancer immunotherapy in patients with advanced melanoma.

An End-To-End Clinical Data Science Platform

See how using Signals Clinical, a SaaS clinical data science platform, can help teams streamline clinical data workflows and reduce the time spent on manual analytics data preparation tasks.


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  • 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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