Clinical operation management

Working with different pharma companies and CROs (Actelion, KCR, BI, GSK, Jansen Cilag, Chiltern Sandoz (Lek)) and considering different monitoring strategies we are able to plan an intelligent and effective project specific concept which fits your needs. With more then 10 years of experience in clinical operations Addomed with its project oriented approach is able to deliver required outcome of the projects within the ultimate quality, for the reasonable budget and within the required time. Professional level of Addomed employees is guaranteed by their experience in clinical research, particularly at different positions in the past. High level of project manager profesionalism has been confirmed in high recruiting clinical trials in Croatia, Serbia and Slovenia (vaccination and cardiology). Every project is handled by the dedicated team of professionals. Project Manager, as a team leader, is responsible for the whole project. With more than a decade of beeing involved in clinical trials as CRA or PM in CEE region, Addomed personnel is highly experienced in all monitoring related activities. Our personnel is responsible for and committed to conduct of all activities in accordance with the protocol, ICH/GCP/ISO requirements, project specific monitoring manual, applicable SOPs and all additional regulatory requirements.

We can help you with regulatory submission strategies and preparation, regulatory meeting preparation and attendance. With a broad range of therapeutic expertise collected through years, our capabilities include clinical operations management, and experience with studies from Phases I-IV.

  • Investigator site evaluation and selection
  • Feasibility studies
  • Submissions to IRBs and regulatory authorities
  • Pharmacovigilance support
  • Investigator meeting planning and preparation
  • Design and organisation of investigational medicinal product supply
  • Clinical trial monitoring
  • Site preparation, initiation, monitoring and close-out
  • Site personnel training and continuous guidance

 

Addomed’s experience with the various subject populations allow us to offer highly educated and experienced project „tailored „teams. Addomed experience with the non-interventional studies provides an extensive and reliable network of the potential investigators.

We have experience in the following therapeutics areas:

Metabolic/Endocrinology (Gaucher's disease)

Psychiatry (Schizophrenia)

Neurology (SAH, migraine, chronic non-malignant pain)

Dermatology (psoriasis)

Cardiovascular (chronic heart failure)

Infectious disease (Clostridium difficile infection)

Immunology (Influenza- Vaccination pediatric study)

Oncology (NSCL)

Rheumatology (Ischemic digital ulcers, rheumatoid arthritis)

Respiratory (IPF, COPD)