As our project managers and CRAs all have medical, pharmacy and life science degrees, we are able to assist and support our clients with their development programs in almost every indication. In addition, our close and friendly relationships with specialists in local teaching hospitals enables us to call upon experts in the treatment of specific diseases to provide specific therapeutic area training to our project teams.
The following graphic provides a breakdown of the therapeutic areas of studies managed in 2016. Currently we are very active in haemato-oncology, cardiology and orphan/rare diseases.
Supporting clients in the organisation and execution of studies with new drugs remains the primary focus of Argint. We have managed and monitored more than 100 clinical studies in a wide variety of indications, the majority having been conducted under an IND.
Historically sponsors opened sites in central and south eastern Europe to rescue studies that were failing due to poor enrolment in USA or western Europe. This has dramatically changed in recent years due the positive experience sponsors have had as regards both patient enrolment and the quality of the work delivered by investigators. Industry is now involving sites in central and south eastern Europe much earlier in development programs and the majority of the studies Argint are currently managing are phase II studies. Biotech companies, reliant on completing POC studies for additional financing, realise the benefit of achieving project milestones faster while minimising costs.
We help our biotech clients avoid costly delays that have the potential to become a serious threat to their ability to survive as a viable company.
Argint is also one of the few European CROs with experience of studies with advanced therapeutics (stem cells). These complex studies require CROs to have unique regulatory and management skills if they are to be successfully executed.
Argint's regulatory group understands the need to communicate closely with regulatory authorities and ethics committees before the study is submitted, thereby ensuring the CTA contains all the information the authorities would like to see. Often these requirements and preferences are not clearly detailed in legislation or guidance documents.
Argint was the first CRO to successfully obtain regulatory and ethics approval in Hungary for a commercially sponsored stem cell study.
While studies with new medications have historically made up the bulk of Argint's business, revisions to European legislation have resulted in the need for more device studies to be conducted. Argint has the expertise to successfully assist clients developing devices. In recent years we have successfully managed a number of device studies, including FIM studies and studies with combination devices.
Phase IV / Observational
Argint has managed retrospective and prospective observational studies and phase IV studies for clients.
One strategy we have implemented for and with clients who are planning studies in very rare and orphan diseases is to initially run a prospective observational study in the chosen patient population. This strategy helps clients gather useful information about patients suffering from the rare disease and existing treatment protocols - which is invaluable for future study design. It also enables Argint and the client find where these very rare patients are being treated and subsequently develop a reliable study plan involving the identified investigators and hospitals which will meet the required timelines of the client.