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Implementing Electronic Data Capture (EDC) systems in Clinical Trials

Clinical Data Management Team

Clinical Trial Management Systems (CTMS) are an important part of every clinical trial. Selecting the right CTMS helps address inefficiencies on the operational side of research, such as clinical trial planning, preparation, performance and reporting. As more and more pharma and biopharma sponsors start to recognize the potential opportunities that exist with EDC-CTMS integration, there is a growing need to address the complex process of electronic data capture (EDC) implementation.

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Topics: Clinical Data Management, Electronic Data Capture, Paper-Based Studies, eCRF, Case Report Form (CRF), CDISC, CDISC CDASH, Outsourcing Solutions

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

Key Considerations When Progressing With an FSP Relationship

Karen Smith


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, Strategic Resourcing, CRO Project, CRO Efficiency, Project Management, Functional Outsourcing, FSP, Total Value Ownership, Outsourcing Solutions

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, Strategic Resourcing, CRO Project, Quality Control, CRO Efficiency, Project Management, Offshore Locations, Functional Outsourcing, FSP, Total Value Ownership, Outsourcing Solutions

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

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

Why Consider Functional Outsourcing by a Functional Service Provider?

Yvonne Moores

One of the key components of a Strategic Resourcing model is the provision of staff through functional outsourcing. This approach has enabled global CROs to deliver genuine value and great customer care to many of the leading pharmaceutical companies around the world as they operate as functional service providers. Underpinning all of a CRO’s FSP (functional service provision) agreements is the commitment to the development of a strong, long-term relationship between the CRO and customer where resources are aligned with the customer’s needs to ensure quality project delivery.

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Topics: Specialist Biometrics CRO, Outsourcing Solutions, Strategic Resourcing, Functional Outsourcing, FSP

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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