Donawa Lifescience Consulting: Device Regulatory - Clinical Studies

DEVICE CLINICAL STUDIES
IN EUROPE AND THE US:
REGULATORY FRAMEWORK
AND BEST PRACTICES

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One-Day Seminar
Wednesday 16 June 2010
ROME, ITALY

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Full Service European CRO

Your CRO partner for successful management of clinical studies in Europe for pharmaceutical and medical device companies

Clinical studies in Europe

With clinical research associates (CRAs) located throughout Europe, Donawa Lifescience Consulting (DLC) is a full-service European CRO, specializing in pharmaceutical and medical device clinical studies. The organization is also expert in medical device and pharmaceutical regulatory affairs, providing a unique combination of skills and experience for the benefit of client companies.

Study management

DLC offers maximum service flexibility, allowing client compaines to use our complete package or only those services needed. The availability of local associates allows efficient site start-up to reduce timescales and costs, while our budget tools provide effective management of budget variations.

Study monitoring

Located throughout Europe, our CRAs, many with both medtech and pharma backgrounds, each have at least 4 years experience in monitoring international studies and communicating with local regulatory authorities and Ethics Committees.

Data management

DLC can provide expert biostatistical and data management support for both drug and device studies, combining cutting edge methodology with vast regulatory experience, to tailor solutions that fit client company's needs.

The DLC European CRO service is managed from our headquarters in the historical centre of Rome, Italy. Contact us either by e-mail for a confidential discussion about your project, or call Daniela Karrer, Director, Clinical Affairs, on +39 06 578 2665.

Regulatory References