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| home > ebr > summer 2019 > leveraging novel therapeutics and diagnostic assays |
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 PUBLICATIONS |
European Biopharmaceutical Review
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| Immunotherapy is far from a novel concept, and its history is intriguing. It all began in 1891 when Dr William B Coley attempted to creatively harness the patient’s immune system. William achieved durable complete remission in several types of malignancies to include sarcoma, lymphoma, and testicular carcinoma by injecting mixtures of live and attenuated bacteria into patients’ tumours. Needless to say, we have come a long way. |
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News and Press Releases |
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Suvoda Introduces Extensible Software Platform Bringing Proven Tech Innovation to Clinical Trial Management
PHILADELPHIA — (February 6, 2023) —
Suvoda LLC, a global clinical trial technology company that specializes
in complex studies in therapeutic areas like oncology, central nervous
system (CNS), and rare disease, today unveiled a purpose-built software
platform designed specifically to provide drug trial sponsors and sites a
seamless way to manage complex, mission-critical, and time-sensitive
moments on the patient journey.
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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