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The Cost Considerations of Outsourcing to a Clinical Research Organization

Commercial Team

Outsourcing as a business practice has been around for centuries and some economists would argue it has been around since man first started providing services to one another. The concept is based on the premise that a specialist company that focuses on a specific functional area can do a better job faster, and at less cost, than a generalist approach whereby you employ all functional areas needed internally. The practice has become entrenched in many areas of industry including the Pharmaceutical and Biotech industry and has fuelled a boom in companies carrying the acronym CRO (Clinical Research Organization).

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Topics: CRO Selection, Outsourcing Solutions, Strategic Resourcing, CRO Project, CRO Efficiency, Clinical Research Organization, Offshore Locations, Clinical Data Services, Functional Outsourcing

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

Celebrating International Clinical Trials Day

Marketing Quanticate

Happy International Clinical Trials Day! For those of you who do not know, International Clinical Trials Day is celebrated each year on 20th May. The event was created to commemorate the day James Lind started the first ever clinical trial to try and cure the deadly disease scurvy.

The clinical trial James Lind conducted consisted of using citrus fruit to cure scurvy. At the time the concept of vitamins were unknown, today we know scurvy is a result of vitamin C deficiency. James Lind was the first to study the effects of citrus fruits by conducting a systematic experiment on sailors in 1747 which is now regarded as one of the first clinical experiments in the history of medicine. 

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Topics: Clinical Trials, Ethics, Clinical Data Services, Statistics, International Clinical Trial Day

Total Value Ownership of selecting a partner for Clinical Development

Daniel Chapple

The first blog post in our “How Total Value Ownership (TVO) can help shape an outsourcing strategy" blog series.

 

Total Value Ownership (TVO) is not a new concept but it is an area that has attracted much interest in recent years. It can help in determining the best approaches to take and suppliers to use, by demonstrating the real value of selecting a certain partner in clinical development.

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Topics: CRO Selection, Outsourcing Solutions, CRO Project, CRO Efficiency, Clinical Research Organization, Clinical Data Services, Functional Outsourcing, Total Value Ownership

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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