Optimapharm
Optimapharm is a leading mid-sized, full-service Contract Research Organization (CRO) operating across Europe and North America. With a focus on delivering high-quality, tailored clinical research solutions, the company supports the development of new therapies to improve and save patients' lives. Established in 2006 in Zagreb, Croatia, it manages numerous clinical trials across various therapeutic areas, including oncology, neurosciences, cardiology, endocrinology, and infectious diseases. The company emphasizes transparency, integrity, collaboration, and flexibility in its operations, aiming to be a trusted partner for its clients.
Industries
Nr. of Employees
medium (51-250)
Services
End‑to‑end clinical development services covering protocol design, regulatory submissions, site operations, monitoring, data management, biostatistics and medical writing for Phase I–IV studies.
Regulatory strategy, preparation and management of clinical trial applications, local adaptations of documents and communications with competent authorities and ethics committees.
Feasibility, site qualification, initiation, ongoing monitoring, close‑out and site training including remote monitoring and audit support.
CRF and database design, EDC and ePRO deployments, query management, data validation, CDISC mapping and consolidation of external data sources.
Statistical design input, SAP development, sample size calculations, randomization, interim analyses, PK/PD modelling and preparation of statistical deliverables for regulatory submission.
Preparation and review of clinical study documents including protocols, informed consent forms, investigator brochures, clinical study reports, scientific manuscripts and regulatory dossiers with quality control processes to meet international standards.
End‑to‑end clinical development services covering protocol design, regulatory submissions, site operations, monitoring, data management, biostatistics and medical writing for Phase I–IV studies.
Regulatory strategy, preparation and management of clinical trial applications, local adaptations of documents and communications with competent authorities and ethics committees.
Feasibility, site qualification, initiation, ongoing monitoring, close‑out and site training including remote monitoring and audit support.
CRF and database design, EDC and ePRO deployments, query management, data validation, CDISC mapping and consolidation of external data sources.
Statistical design input, SAP development, sample size calculations, randomization, interim analyses, PK/PD modelling and preparation of statistical deliverables for regulatory submission.
Preparation and review of clinical study documents including protocols, informed consent forms, investigator brochures, clinical study reports, scientific manuscripts and regulatory dossiers with quality control processes to meet international standards.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Data management and CDISC implementation
- Biostatistics and statistical programming
Key Technologies
- Clinical Trial Management System (CTMS)
- Electronic Data Capture (EDC) platforms
- ePRO and patient‑reported outcome platforms
- Interactive randomization systems (IXRS/IVRS)
News & Updates
Optimapharm announces the appointment of Paul Miller as Chief Commercial Officer, bringing over 15 years of experience in the industry.
Optimapharm announces Pavle Vukojević as Chief Medical Officer, with over 25 years of experience.
An interview discussing the first experiences with CTIS and its impact on EU clinical research.
Optimapharm announces Jelena Pavlović as Senior Director, Trial Support, effective August 2023.
Optimapharm announces the appointment of Paul Miller as Chief Commercial Officer, bringing over 15 years of experience in the industry.
Optimapharm announces Pavle Vukojević as Chief Medical Officer, with over 25 years of experience.
An interview discussing the first experiences with CTIS and its impact on EU clinical research.
Optimapharm announces Jelena Pavlović as Senior Director, Trial Support, effective August 2023.