Clinical development from phase I to marketing approval. <<

When biotech and small to mid-size pharmaceutical companies face clinical development of their products, they face various challenges:

• How should the clinical development be structured to support approval by the authorities later on ?
• Is the preclinical data package sufficient to start a phase I ?
• Which is the best CRO for each study at what price ?
• How to establish and secure the in-house expertise to oversee and coordinate the various consultants and CRO's

van Rooijen & Partners cooperate with Accovion, a CRO experienced to serve the full clinical development from phase I to marketing approval, and therefore provides a solution to overcome these challenges.

This approach offers the advantage of one experienced and dedicated team managing the whole process without the hassle of "CRO-shopping" for each individual study. In addition, while this team gains thorough knowledge of the specific development product, efficiency is increased.

Accovion has expertise and experience of specific use:

• In the main indications: Oncology, Cardiology, Metabolism and Diabetes, Inflammation and Rheumatology, Immunology, Hematology, Neurology and Psychiatry, Dermatology, Allergology, Anti-Infectives, Plasma Proteins, Vaccines, Pediatric medicine
• Full clinical development and registration
• Up to 20 years of experience in more than 25 countries
• Small molecules, peptides, proteins, antibodies
• An investigator database of more than 25,000 entries
• More than 100 phase II and II clinical studies
• More than 20 approved submissions in Europe and the USA

With 200 employees Accovion is big enough to handle large international study programs and small enough:

• to understand the "biotech language"
• to handle also small projects with high priority
• to dedicate an expert team including senior experienced employees to each project
• to decide and move fast in order to keep tide time lines
• to provide costumer tailored services according to individual needs

For further information, please contact Dr. Joe Bender (JB@vr-p.com, phone +49-2053-4254947) or Dr. Lucio A.A. van Rooijen (LvR@vr-p.com, phone +49-8847-699726).

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