Contract Research

Flexibility as a Core IND Strategy
With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more
The Operational Foundations That Characterize Regulatory Leaders
Holding individuals and teams explicitly accountable for data accuracy and quality might seem straightforward, but it is difficult to sustain in practice. read more
Rethinking the Architecture of Adverse Event Processing
Deploying AI agents to handle data collection, coding, medical review, and quality-checking makes signal management autonomous at the processing stage. read more
Five Steps to Smooth Agentic AI Adoption
In agentic AI-enabled labs, AI goes from individual, one-off applications to comprehensive workflow orchestration. read more
Leveraging AI and ML to Optimize Drug Discovery – a CRO Perspective
CROs supporting early-stage drug discovery projects are establishing their own internal AI platforms to address their clients’ needs in an evolving field. read more
Status Of AI Regulation On Drug Development
As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the ... read more
Hasty Decisions, Runaway Projects
Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. read more
Future-Proofing Pharmacovigilance in an AI Era
Clinical research organizations (CROs) are entering an era in which pharmacovigilance systems are doing more than just tracking copious amounts of data. They must also keep pace with evolving regulations, manage the growing volume of adverse event ... read more

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VectorBuilder, Lir Partner to Engineer More Manufacturable AAV Capsids
VectorBuilder and Lir Therapeutics have formed a strategic collaboration to develop adeno-associated virus capsids designed to combine biological performance with the manufacturability and scalability needed for clinical gene-therapy programs. read more
Charles River, Medigen Partner on Multivalent Enterovirus Vaccine
Charles River Laboratories International and Medigen Vaccine Biologics Corp. have formed a collaboration to support development of Medigen’s next-generation multivalent enterovirus vaccine through next-generation sequencing and other analytical and non-clinical capabilities. read more
Cytovance Adds Standalone Analytical Services
Cytovance Biologics has launched standalone analytical services for biopharmaceutical companies, allowing clients to access analytical testing without also using the company for development or manufacturing. read more
Piramal Pharma Takes Controlling Stake in Yapan Bio
Piramal Pharma Ltd. has completed the acquisition of an additional 40.67% stake in Hyderabad-based biologics contract development and manufacturing organization Yapan Bio Private Ltd., raising its ownership to 74% and making the company a Piramal subsidiary. read more
Clinilabs Names Laura Shannon CEO; Founder Gary Zammit Becomes Executive Chair
Clinilabs has appointed biopharma executive Laura Shannon as chief executive officer and promoted founder Gary Zammit, Ph.D., to executive chairperson as the specialty contract research organization expands its global capabilities in central nervous system drug and device development. read more