CRO Strategic Partnerships

Budding Relationships

Karyn Korieth at CenterWatch discusses how using performancebased metrics in site selection can help CROs to establish long-term relationships with those sites who are capable of delivering high-quality clinical data faster and more efficiently.

Annual CRO Review

The Race Towards Strategic Outsourcing?

EPC’s Editor Graham Hughes reviews the CRO market in 2011, placing a strong emphasis on mergers, acquisitions, joint ventures and strategic alliances as an indication of what is to come in the industry.

Clinical Patient Databases

The Population Pool

Efficient patient recruitment is one of the greatest challenges to clinical trial sponsors and can often cost many months in valuable research time. Joseph Azuri at Maccabi Healthcare Services explains how patient databases can be used to define the optimal subject population.

Patient Recruitment: Europe

Pick and Mix

Selecting the right media platform for the recruitment of study participants in Europe depends on the individual indication and criteria of the clinical trial.Whatever the method, it is important to present enough information to provide answers to the most frequently asked questions, states Nils Drew at Clariness.

Regulatory Viewpoint: India

Firm Foundations

The Indian pharmaceutical industry is the third largest in the world in terms of volume and is currently valued at about $400 million. While this is a great milestone for the region, a strong regulatory framework is essential in order to avoid losing momentum, assert Ajit Nair and Rajendra Talele of SIRO Clinpharm.

Medical Devices: MDD Recast

Mark of Approval

Erdmann J Zippel at D-TARGET (a Premier Research Company) provides an insight into how the amendment to the Medical Device Directive has changed the approval process and has had a positive effect on patient safety, citing examples from countries in the European Union.

Immunometabolism

New Therapeutic Avenues

It has become increasingly clear that the accumulation of vast amounts of fat in adipose tissue is linked to significant alterations in the immune system. Our increased understanding of the relationship between the two will help in the treatment and prevention of obesity-related disorders, explains Joseph A Cornicelli atCharles River Discovery Services.

Medical Devices: Paediatrics

In Small Doses

Andre Muelenaer at Carilion Clinic Children’s Hospital and Alfred L Wicks at Virginia Tech University give an insight into the structure and activities of the Paediatric Trials Network and its strategic partnerships to promote the development of devices for children.

Autoimmune Disorders: MENA Region

Unmet Needs

As autoimmune diseases become more widespread in the Middle East and North Africa, Rani Abraham at ClinTec stresses the need for more clinical trials to be performed locally, discussing those diseases with the highest incidence in the region.

Medical Devices: Development

Ergonomically Sound

Michael P Craven and Jennifer L Martinof the Faculty of Engineering at the University of Nottingham, Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) discuss the crucial role of the end-user in the medical device product development pathway.

CDISC Update

Strength Through Collaboration

Lauren Shinaberry of PRA, and chair-elect of the CDISC Advisory Board for 2011, provides an insight into CDISC’s vision for the future and how the organisation intends to make full use of the opportunities new technology is offering.

Early Clinical Drug Development

Flexible Study Designs

David Underwood at Quanticate provides an overview of the ways in which Phase 1 packages can be conducted more efficiently using combination, flexible protocols to speed up the time to becoming Phase 2 ready.

Global Clinical Trials: MENA Region

Shifting Sands

The Middle East and North Africa region is an exciting emerging market growth opportunity.Vladimir Misik of Quintiles presents an in-depth analysis of the region as a destination for R&D.