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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

Key Considerations When Progressing With an FSP Relationship

Karen Smith

fsp_relationship.jpg

Functional Service Provider (FSP) relationships are becoming more commonplace within the Pharmaceutical Industry.  The aim of such a relationship is a jointly beneficial commercial and financial model which will continually drive improvements in quality and maximise efficiencies and value for the customer.  Collaboration is often defined by company and business goals which can be changeable, and has flexibility to evolve as the business develops which strengthens relationships further.

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Topics: Clinical Trials, CRO Selection, Outsourcing Solutions, Strategic Resourcing, Quality Process Improvement, CRO Efficiency, Functional Outsourcing, FSP

How the Hierarchy of Teams Affects the Cost of Clinical Development

Daniel Chapple

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

The location of staff within a functional partnership in clinical development was discussed in a previous blog, but this is closely linked to the experience of staff and where the different levels of experience reside. Having a solution primarily focused around graduates in a low cost area vs. a solution based around experienced team members in a higher cost location can have significant impacts on the cost of clinical development projects. It is likely that any proposed solution will incorporate both sides and understanding the exact make-up of the team will provide some insight into what the Total Value Ownership (TVO) is likely to end up being.
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Topics: Clinical Trials, CRO Selection, Outsourcing Solutions, Strategic Resourcing, CRO Project, CRO Efficiency, Project Management, Functional Outsourcing, FSP, Total Value Ownership

7 Considerations of Global Resources in Clinical Development Partnerships

Daniel Chapple

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

Project costs in clinical development partnerships can be influenced significantly by the location of staff since salary levels differ widely depending on where the staff members are located. The percentage and mix of staff in different locations can provide a cost-effective solution, but it can also provide a solution that compromises quality if the mix is not right. Whilst the initial costs may decrease and help to build a business case, the Total Value Ownership (TVO) may not look so attractive when taking into account the oversight and other costs associated with the deliverables. Any projects that move off their critical paths can also have significant impacts to the overall TVO, particularly if this results in delays of submissions and ultimately launch. 

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Topics: Clinical Trials, CRO Selection, Outsourcing Solutions, Strategic Resourcing, CRO Project, Quality Control, CRO Efficiency, Project Management, Offshore Locations, Functional Outsourcing, FSP, Total Value Ownership

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

Challenges and Rewards of Working in a Clinical Research Organization

Medical Writing Team

The business of Clinical Research Organizations (CROs) has been expanding recently due to the slow growth in the pharmaceutical industry. Working for a CRO offers numerous challenges and rewards. The following highlights some of these in greater detail:

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Topics: CRO Selection, Specialist Biometrics CRO, CRO Project, Clinical Research Organization, Request For Proposals

Making a Clinical Research Organization Project Run Smoothly

Commercial Team

When embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a project runs smoothly from the start. Following a formalised handover from business development to operations, a face-to-face kick off meeting is important.

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Topics: CRO Selection, Specialist Biometrics CRO, Outsourcing Solutions, Strategic Resourcing, CRO Project

10 Considerations of Offshore Locations to Support Clinical Trials

Daniel Chapple

There has been increased interest across the life sciences industry to use lower cost regions such as India, China, Eastern Europe, South America and South Africa to support functions including clinical data management, statistical programming, biostatistics, pharmacovigilance and medical writing within clinical development and safety monitoring areas.

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Topics: Clinical Trials, CRO Selection, Outsourcing Solutions, Offshore Locations

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