Optimum CRO was established in 2000 as one of the first CROs in Turkey.
Optimum CRO and its team has a deep experience over the clinical trials of different phases and post marketing surveillance studies.
Optimum CRO has CRAs, PMs, QC, SCs and data management units that are located in the main office based in Ankara, the capital city of Turkey.
With its high development rate, Optimum CRO is one of the leading and experienced foundations for conduct, organization and improvement of clinical researches in Turkey.
We provide;
Project Set-Up Services (Ethics Committee and Regulatory Authority Submissions, Meeting Organisations, Clinical Trial Trainings, Site Selection and Feasibility Activities, Import License and Customs Clereance, Contract Negotiations)
Clinical Project Management Services (Project and Site Management for Phase I – IV Clinical Trials, Post Marketing Survellience Studies, Registry Studies, ATMP Studies, Compassionate Use and Medical Device Studies, Bioequivalence&Bioavailibility Studies, Monitoring Services for all these trials, Site Coordinator Services)
Medical Services ( Medical Writing, Informed Consent Form Design, Case Report Form Design- both paper and electronic-, Protocol Design, Clinical Study Report Design, Data Management, Statistical Analysis Report Preperation, Statistics Trainings, Medical Translation)
Optimum CRO has a wide range of experience in different therapeutic areas including; Chest and Respiratory Diseases, Physical Medicine and Rehabilition, Oncology, Hematology, Endocrinology, Rheumatology, Cardiology, Radiation Oncology, Allergy, Neurology, Ophthalmology, Infectious Diseases, Gynecology, Urology, Nephrology, Psychiatry, Gastroenterology, CNS, Dermatology, Metabolism, General Surgery, Pediatry, Brain Surgery, Pharmacology, Pediatry Hematology, Orthopedy and Cardiovascular Surgery.
Different types of trials such as; Clinical Trials, Post Marketing Trials, Site Management Organization, Electronic Data Capture and Compassionate Use are being conducted by Klinar CRO.
Optimum CRO has its self-check systems to provide improvement and control of quality in management of clinical studies. These systems consist of regular internal checks which are performed by Quality Control unit. High quality is maintained throughout the trials by means of;
• SOP compliance
• Co-monitoring / internal audit visits
• Project related document (both electronic and hard copy) controls
· Clinical trial supplies accountability
• Ensuring availability of essential documents
• Maintenance of archiving system
• SOP trainings (both company and sponsor SOPs)
Optimum CRO has comprehensive and detailed SOPs to guide and train all staff, to ensure operations to be carried out in compliance with ICH/GCP and regulations to fulfill the sponsor companies’ requests and requirements.In addition, in Optimum CRO’s project management system, it is always possible to work with sponsor companies’ SOPs.
With our extensive background in this field, our specialized team and with the philosophy of continous improvement, we are ensuring to provide the services you need with the excellent process.
Our vision is to become a leader in the World starting from Turkey in the healthcare trials as a high quality service provider.
As Optimum CRO we have
– Expertise in local regulations
– Experienced teams
– A wide range of therapeutic area experience
– Presentable leaders
– Good relations with local ECs and Regulatory Authorities
– Harmonious quality systems and continous quality control
– Succesful Audits
– Well trained ICH/GCP Knowledged Project management teams
– Possibility to work with sponsor SOPs
– Good time management and budger management of projects
