ABR’s clinical services focus on preparing, initiating, executing, and reporting of clinical trials in an efficient and timely manner. Our team possesses extensive practical experience in both industry and academia, providing an optimal balance between research and commercial needs. 

 

Our clinical services include:​

• Clinical trial management: Oversee and coordinate all aspects of a clinical trial from start to finish, ensuring adherence to protocols and regulatory guidelines.

• Site selection and management: Identifying and qualifying investigational sites with the necessary infrastructure and patient populations, followed by initiation, training, monitoring, and support for those sites.

• Patient recruitment and retention: Developing strategies and leveraging networks to identify, enroll, and retain eligible participants, crucial for meeting trial timelines and targets.

• Clinical monitoring: Conducting regular visits to trial sites to assess protocol adherence, data accuracy, patient safety, and adherence to Good Clinical Practice (GCP) guidelines.

• Data management: Establishing robust data collection processes and systems (like Electronic Data Capture or EDC), ensuring data accuracy, integrity, and security and compliance with regulatory requirements and industry standards.

• Biostatistics: Providing expertise in study design, sample size determination, statistical analysis plans, interpreting data, and creating reports for regulatory submission.

• Medical writing: Preparing essential documents such as protocols, clinical study reports, and regulatory submissions.

• Regulatory affairs: Navigating complex global regulatory requirements, preparing and submitting regulatory documentation (e.g., to the FDA or EMA), and ensuring compliance throughout the trial.

• Pharmacovigilance: Monitoring and reporting adverse events, assessing risks, ensuring patient safety, and maintaining compliance with safety regulations. 

• Quality assurance: Clinical Site Audits, Database Audits, Site Qualification/Audits, Vendor Audits, and GLP/GMP Audits.

• Training: Good Clinical Practice (GCP) which ensures the safety and integrity of clinical trials. This training covers the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. Other types of training include introductory courses, specialized training in areas like biostatistics or protocol development.