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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

Making Metric Collection Obligatory in Clinical Trial Contracts

Medical Writing Team

Establishing robust metrics at the start of a study, and systems to monitor them in an ongoing manner, should be integral to all work that a Clinical Research Organisation (CRO) performs. There is an expectation from clients that metrics will be used to monitor progress or lack of progress, including deviations from the planned schedule. However, these metrics are sometimes not defined clearly at the outset and often not incorporated into clinical trial contracts. A lot of metrics need to be “balanced” between what is controllable by the CRO and what is controllable by the sponsor. Therefore, the metrics that are incorporated into a contract need to be carefully chosen. Ideally it should be a small and accurate set of performance metrics that will meet the customer’s needs and enforce efficient information flow – it being a breach of contract not to provide and review the metrics.

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Topics: Metric Collection, Clinical Trial Contracts, Clinical Trials, CRO Project, CRO Efficiency, Project Management

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

4 Efficiencies of a Clinical Research Organization

Commercial Team

How can the efficiency of a Clinical Research Organization (CRO) be understood? As CROs provide various services to study sponsors, their overall efficiency at providing these services and internal processes to allow these to be delivered can be broken down into a number of elements with their own unique efficiency.

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Topics: CRO Project, CRO Efficiency, Clinical Research Organization, Visualization, Micro Efficiencies, Project Management

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

Nick Burch Discusses Big Data in Clinical Trials [Video]

Nick Burch

Nick Burch, CTO at Quanticate discussed Big Data in Clinical Trials at the 4th Annual Clinical Data Integration and Management conference this year in Princeton, NJ. His presentation is titled: 'The Myth of the Big Data Silver Bullet - Why Requirements Still Matter'

Abstract

We've all heard the hype - Big Data will solve all your storage, processing and analytic problems effortlessly! Some moving beyond the buzzwords find things really do work well, but others rapidly run into issues. The difference usually isn't the technologies or the vendors per-se, but their appropriateness to the requirements, which aren't always clear up-front.

Big Data, and the related area of NoSQL, are actually a broad range of technologies, solutions and approaches, with varying levels of overlap. Sadly it's not just enough to pick "a" Big Data solution, it needs to be the right one for your requirements. In this talk, we'll first do a whistle-stop tour of the different broad areas and approaches of the Big Data space. Then, we'll look at how Quanticate selected and built our Big Data platform for clinical data, driven by the needs and requirements. We won't tell you what Big Data platform you yourself need, but instead try to help you with the questions you need to answer to derive your own requirements and approach, from which your successful Big Data in clinical trials solution can emerge!

 

Big Data in Clinical Trials Video 

 

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Topics: Clinical Trials, Clinical Data Storage, FDA, Clinical Study Design, Large Datasets, CRO Efficiency, Visualization, Accessible Data, Mobile Device, Big Data, Drug Development, Technology Trends

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

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