Qualitis
Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives. They have extensive expertise in oncology, rare diseases, neurology, cardiology, endocrinology, respiratory, gastrointestinal, and dermatology, with a focus on tailored, flexible, and collaborative approaches across all phases of clinical development in various therapeutic areas including medical devices. The company emphasizes ethics, compliance, patient safety, and high-quality data management, supported by a strong network of experienced staff and trusted relationships with key opinion leaders.
Industries
Nr. of Employees
medium (51-250)
Products
Therapeutic-area factsheets (Oncology, Rare Diseases, Neurology, Cardio-Endo-Metabolic, Respiratory, GI/GU)
Downloadable factsheets summarising therapeutic-area experience, indicative site networks, and key performance metrics to support study feasibility and sponsor briefings.
Therapeutic-area factsheets (Oncology, Rare Diseases, Neurology, Cardio-Endo-Metabolic, Respiratory, GI/GU)
Downloadable factsheets summarising therapeutic-area experience, indicative site networks, and key performance metrics to support study feasibility and sponsor briefings.
Services
End-to-end clinical trial services covering study design, project management, monitoring, data management, biostatistics and regulatory support for pharmaceutical, biotech and medical device sponsors.
Preparation of regulatory dossiers, part I/II documentation, CTIS submissions and transition activities to meet EU CTR requirements.
Site identification, contract and budget negotiation, ethics submissions, site initiation and green-light approval coordination.
Interventions to recover underperforming trials including site expansion, recruitment strategy revision and operational remediation.
Safety oversight, SAE handling, aggregate safety reporting and medical monitoring services for clinical studies.
Implementation and globalisation of eTMF processes, integration with CTMS and document management systems, plus related SOPs and training.
End-to-end clinical trial services covering study design, project management, monitoring, data management, biostatistics and regulatory support for pharmaceutical, biotech and medical device sponsors.
Preparation of regulatory dossiers, part I/II documentation, CTIS submissions and transition activities to meet EU CTR requirements.
Site identification, contract and budget negotiation, ethics submissions, site initiation and green-light approval coordination.
Interventions to recover underperforming trials including site expansion, recruitment strategy revision and operational remediation.
Safety oversight, SAE handling, aggregate safety reporting and medical monitoring services for clinical studies.
Implementation and globalisation of eTMF processes, integration with CTMS and document management systems, plus related SOPs and training.
Expertise Areas
- Clinical trial management
- Regulatory affairs and EU CTIS/CTR submissions
- Site activation and start‑up management
- Patient recruitment and investigator networks
Key Technologies
- EU CTIS / Clinical Trials Regulation (CTR) implementation
- Electronic Trial Master File (eTMF) systems
- Clinical Trial Management System (CTMS) and document management integration
- Adaptive / seamless Phase II/III trial design
News & Updates
We deliver on your promises with a new office in Boston to support North American operations.
Ana Stojković to speak on Person-Centric Clinical Trials at EUCROF webinar.
Participation in key industry conferences to showcase expertise.
Strategic acquisition to expand capabilities.
Strengthening clinical trial network through acquisition.
Leadership change to support strategic growth.
We deliver on your promises with a new office in Boston to support North American operations.
Ana Stojković to speak on Person-Centric Clinical Trials at EUCROF webinar.
Participation in key industry conferences to showcase expertise.
Strategic acquisition to expand capabilities.
Strengthening clinical trial network through acquisition.
Leadership change to support strategic growth.