|Articles|October 12, 2017

SGS and Bavarian Nordic to Develop a Challenge Model for Respiratory Syncytial Virus

SGS has collaborated with Bavarian Nordic to develop a novel and differentiated challenge model for respiratory syncytial virus. This partnership brings both expertise and a view of wanting to bring a life changing therapy to the market. This new model will assist with the advancement of a universal vaccine candidate designed to induce protective immune responses against both subtypes (A & B) of RSV.

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FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations

A new white paper and public engagement process outline the FDA’s commitment to building fit-for-purpose evidentiary standards, stronger patient voice integration, and greater regulatory predictability across rare disease drug development and review.

© putilov_denis - © putilov_denis - stock.adobe.com

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Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection

Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.

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ACT Brief: Design Drivers of Trial Representation, eSource-to-EDC Data Automation, and Roche's ALK7 Obesity License

In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.

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IgniteData and RealTime Partner to Streamline Clinical Data Transfer From eSource to Sponsor Systems

The partnership gives RealTime's network of more than 3,000 research sites access to the Archer platform for direct, automated data transfer from eSource to any sponsor electronic data capture system or data destination.

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The Biggest Remaining Barriers to High-Quality RWE Across Oncology Data Platforms

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, identify three persistent obstacles to consistent real-world evidence generation in oncology—inconsistent data capture, structural data limitations that modeling alone can't fix, and the need for earned generalizability through deliberate multi-site validation.

A case study of how an emerging biotech moved from targeted monitoring to full clinical operations and site management across multiple studies. Credit: Stock.Adobe.com/PHOTO4U

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Flexible Clinical Operations and Site Management Across a Diversified Biotech Portfolio: An Application of Quality by Design and Risk-Based Oversight

How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.

Representation gaps in clinical trials are built into protocol, eligibility, and site decisions, not just recruitment efforts. Credit: Stock.Adobe.com/KHAN VECTOR CO.

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Beyond Outreach: Structural Drivers of Representation in Clinical Trials

The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long before the first patient is screened.

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What a Practical Roadmap for FDA and EMA Quality Frameworks Actually Looks Like

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.

SGS and Bavarian Nordic to Develop a Challenge Model for Respiratory Syncytial Virus

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IgniteData and RealTime Partner to Streamline Clinical Data Transfer From eSource to Sponsor Systems

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