AtoZ-CRO Clinical Trial Management Services for Pharmaceuticals and Medical Devices
AtoZ-CRO plans and conducts international clinical trials, specialising in patient recruitment and site monitoring for phases 0-IV, in addition to post-marketing studies.
The company designs trials for pharmaceuticals and medical devices, taking responsibility for pharmacovigilance (PV), biometry, statistical activities, medical writing and translation.
AtoZ-CRO conducts clinical studies for pharmaceuticals and medical devices. It has organised more than 300 studies for indications ranging from dermatology, haematology and immunology to neurology, oncology and respiratory disease.
Clinical study design services for phases 0–IV
AtoZ-CRO’s team of highly experienced professionals and medical specialists manage and coordinate clinical studies internationally.
Its high-quality services comprise planning, the preparation of study protocols, designing and implementing electronic case report forms (eCRF), as well as managing regulatory affairs issues.
AtoZ-CRO works closely with a reliable partner to offer biometry and statistics services such as data collation, validation, analysis and reporting, including sequential collation.
Patient recruitment and site monitoring services for medical trials
AtoZ-CRO has a global network of monitors and investigators. The company closely collaborates with leading professionals to ensure short recruitment periods and effective sourcing of experienced staff at study sites.
Conducted in Eastern Europe, the trials enrol drug-naïve, highly compliant and motivated subjects, which lead to low dropout rates. This leads to reduced costs per patient and turnaround times in meeting recruitment goals.
AtoZ-CRO plans and conducts clinical studies, recruits and assesses study centres, trains investigators and staff, and completes source data checks and reports. The company communicates with investigators sponsor regarding the provision of required supplies and documentation.
Pharmacovigilance services and adverse drug reaction reporting
AtoZ-CRO collates, processes, analyses and notifies adverse drug reactions (ADR) that occur during clinical studies. The company submits serious unexpected serious adverse reactions (SUSAR) and Individual Case Safety Reports (ICSR) to European regulatory authorities and the Commission for Environmental Cooperation (CEC).
The firm also provides European Medicines Agency (EMA) certified safety monitoring for the economics to business (E2B) submissions of SUSARs and ICSRs.
In addition, AtoZ-CRO offers medical, clinical and safety regulatory affairs in the EU and a 24-hour physician standby service.
AtoZ can handle issues that require a local qualified person for pharmacovigilance (LQPPV).
Quality management for audit preparation
AtoZ-CRO’s quality management department conducts independent audits of study documents such as clinical study protocols, subject information sheets, informed consent forms, case report forms and clinical study reports. Investigator sites, databases and trial master files (TMF) can also be assessed.
The company organises external supplier audits for interactive voice recording systems (IVRS), electro-cardiology (ECG) and clinical trial supply chain management.
AtoZ-CRO also offers translation and medical writing services, as well as training and seminars.
Founded in 1984, AtoZ-CRO has international experience in clinical trial management and cooperation with highly rated business partners. The company offers a wide variety of services to meet clinical research requirements, ranging from initial planning stages to the final integrated study report.
AtoZ-CRO is affiliated with a leading initiator of Phase I studies in Warsaw, Poland. The Phase I unit is within close proximity to a number of hospitals.