Outstanding support in first-hand drug development and registration

Although we are a mid-sized CRO, we have often worked with first-in-class drug products that usually consist of new, very challenging professional issues and a network of complex and interconnected pathways from both scientific and regulatory point of view. Usually this continuous work on finding new ways and solving the unexpected problems are the most significant cost generators in a study.

Over the past two decades, we have experienced that innovative drug development requires a special mixture of expertise, creativity and significantly different approach from the usual clinical development routines.

Accelsiors offers real professional support in managing the complexity of your study and deliver your treatment to the market in the most time and cost efficient way possible.

We firmly believe that efficient and successful clinical trial conduct is impossible without professional competence, in-depth knowledge, flexibility and a proper scientific and medical understanding of investigational products and studied indications. Keeping this in mind, we developed our operating approach to maximize the value of your drug development program.

Take advantage from our broad experience and professional background in finding new ways in innovative drug development!

• In the last two decades, Accelsiors gained considerable experience in the development of innovative biologics, targeting the epigenetics or molecular immunology mechanisms.
• Our experience spans from small molecules to complex therapeutic proteins like monoclonal antibodies, or vaccines for a wide range of therapeutic areas and indications,
• including innovative products which had no appropriate regulatory framework existing.
• Accelsiors’ professionals were among the pioneers in the biosimilars field, guiding and supporting biosimilar development programs and registrations from 1996 with the first biosimilar product ever approved in the world.
• We run unique professional events and short courses in Biometrics, Biosimilars, Targeted nanomedicine development aimed at increasing effectiveness of futuredrug development and in order to provide effective support in sharing recent scientific and practical knowledge.

We can help shaping any aspect of your development

We not only monitor a study! Through our integrated consulting solution called StrongCore Scientific™ we provide you a customizable, best-in-class scientific support delivered by Accelsiors’ regulatory, statistical, medical and translational science experts, complemented by prominent subject matter specialist consultants from various fields of drug development.

StrongCore Scientific™ is a flexible, fit-for-purpose advisory solution. The team is always uniquely composed for a study, members are selected and involved in harmony with the special development needs. Through our solution you will gain access to a multidisciplinary team of experts with advanced professional background in life sciences and regulatory, in-depth practical knowledge of the therapeutic area, significant experience and expertise across the entire drug development industry, who

• understand your needs.
• the associated challenges and opportunities in your study,
• tailor the clinical development or project strategy
• who are able to scientifically contribute, interpret data in its real context,
• and advise you concerning the optimal strategic directions at any stage of the study.

Learn More About Accelsiors’ Flexible Capabilities

Let us support you to manage the complexity of your development program and help to deliver your treatment to the market on-time, on-budget successfully!