AtoZ-CRO provides services and partner solutions for clinical studies with pharmaceuticals and medical devices.
Planning of clinical trials
AtoZ-CRO plans and performs clinical studies for pharmaceuticals and medical devices, which includes dermatology, hematology, immunology, internal medicine, neurology, oncology and respiratory diseases.
The company specialises in pharmacovigilance, biometry and statistical services, as well as medical writing and translation.
AtoZ-CRO co-ordinates clinical studies up to Phase IV and post-marketing studies for national and international clients, and has successfully completed rescue and feasibility studies.
AtoZ-CRO has a team of experienced medical specialists to ensure high standards of clinical study management. The company prepares study protocols, and designs and implements electronic case report forms (eCRFs) and regulatory affairs issues.
Short-time patient recruitment
AtoZ-CRO has a network of local monitors and investigators in Germany, Eastern and Western Europe, the US and India.
Studies in Eastern Europe offer drug-naïve, compliant and motivated subjects, and a low drop-out rate for lower costs per patient and fast completion of recruitment goals.
AtoZ-CRO offers assessment and monitoring of study centres, as well as staff and investigator training. This includes source data checks, reporting and communication with investigators and the sponsor, as well as the provision of study centres with supplies and documentation.
Pharmacovigilance of medication
AtoZ-CRO performs the collating, processing, analysing and notifying of adverse drug reactions (ADRs) during clinical studies.
The company submits suspected unexpected serious adverse reactions (SUSARs) and individual case study reports (ICSRs) to European regulatory authorities and CECs.
AtoZ-CRO also provides European Medicines Agency (EMA) certified safety monitoring for E2B submissions of SUSARs and ICSRs. Medical, clinical and safety regulatory affairs in the EU and a 24hr physician standby service is included.
Biometry and statistics services
To successfully complete a study, AtoZ-CRO offers its biometry and statistics services, including data collation, validation and reports, as well as sequential collation and analysis.
AtoZ-CRO has a quality management department that conducts independent audits of documents such as clinical study protocols, subject information sheets / informed consent forms and case report records.
The company provides audits of investigator sites and external suppliers, as well as database and trial master files, including service providers such as IVRS, ECG, clinical trial supply chain management and internal system audits.
Medical translation and writing
AtoZ-CRO offers medical translation and writing services, as well as training and seminars.
The company provides International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and good clinical practice training (GCP) training for investigators, nurses and CRAs.
About Clinical Research Organisation, AtoZ-CRO
AtoZ-CRO offers a range of services covering all clinical research needs for small and mid-sized pharmaceutical, biotech, and medical device companies.
Based in Overath, Germany, AtoZ-CRO is also affiliated with a leading initiator of Phase I studies in Warsaw, Poland.
