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A Guide to the Benefits of Centralized Clinical Data

Commercial Team

If a pharmaceutical, biotech or medical device company outsources its clinical trials, it may be neither practical nor advisable to use one single Clinical Research Organization (CRO). Smaller CROs may not have the infrastructure to deliver large multinational trials, and large CROs may not offer the level of attention or flexibility required for smaller, but no less important, clinical studies. However, whilst the choice of CRO may be study dependent for the clinical aspects (such as patient recruitment, monitoring, clinical project management and regulatory expertise) there are tangible advantages to centralizing all data handling activities with a single provider – one that supports clinical data management, biostatistics, pharmacovigilance and medical writing services.

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Topics: Clinical Trials, CRO Selection, Clinical Data Storage, Centralization, CRO Project, CRO Efficiency, Clinical Data Services, Functional Outsourcing

How Well Written Proposals Affect Clinical Research Organization Selection

Commercial Team

Selecting the right Clinical Research Organization (CRO) is vital to the success of any clinical study. Get it right and the months that follow will be that much more enjoyable because the study is more likely to run smoothly and stay within budget. Those sponsors who have had to transition a clinical study away from a poorly performing CRO to an alternative supplier, mid-study, will be acutely aware of the pain that this can cause and the need for a thorough vendor selection process. The Request For Proposal (RFP) is a vital component of that process. A well-defined and comprehensive RFP creates the best chance of selecting the most appropriate CRO, or combination of CROs, to complete the project.

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Topics: CRO Selection, Centralization, CRO Project, CRO Efficiency, Clinical Research Organization, Clinical Data Services, Request For Proposals

14 Advantages of Data Centralization and Standardization in Clinical Trials

Clinical Programming Team

The most crucial element of all research and development in clinical trials is the data.  It is the end product of every experimental and clinical study and supports the label of every product on the market.  It is required for internal decision making, the achievement of regulatory approval, and for monitoring and ensuring the safety of any clinical drug or device in the market. 

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Topics: Clinical Trials, CDISC, Standardization, SDTM, Centralization

How a Centralized Approach to Data Impacts Clinical Study Design

Statistical Consultancy Team

 

In today’s environment, one of the keys to accelerating drug development decisions comes from ready access to historical data. The introduction of the Centralized Service Provision (CSP) enables data across study phases and programmes to be accessed as easily as within the same study, due to the commonality of structure.

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Topics: Standardization, Clinical Study Design, Centralization, Biostatistics Consulting, Visualization

The Benefits of Centralizing Clinical Data Services

Commercial Team

When Sponsors select a CRO, most make their choice based on the CRO’s clinical experience, locations, capacity, expertise and of course price. They then assign the 'back end services' such as data management, statistical analysis and reporting to the same CRO by default. This practice overlooks the practicalities and economies of centralizing their clinical data for all study programs. This blog explores the advantages of centralizing those 'back end' services whether it is internally by the Sponsor, with a full service CRO or with a specialist biometrics CRO.

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Topics: Centralization, Specialist Biometrics CRO, Outsourcing Solutions, Accessible Data, Clinical Data Services

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