ORGANIZING AND MANAGING CLINICAL STUDIES
Our IT solution builds on the concept of a data warehouse and embraces all aspects of our organization by linking the day-to-day management of clinical trials from regulatory requirements through to the administrative realm of clinical research.
In the past years, this has been a major investment with the objective to streamline and improve the management of clinical trials, and thus help you as a sponsor, to be more cost efficient.
We employ highly qualified and experienced life-sciences professionals. With our rigorous quality management system and continuous training of personnel, we can guarantee top quality services to our customers.
Partner with CR2O to tap into our accumulated experience of 400 studies in over 30 countries.
From protocol development to clinical monitoring, we are here for you every step of the way.
CR2O CRAs are highly qualified life-science professionals who undergo a rigorous training phase in addition to continuous training throughout their careers at CR2O. Our CRAs perform all activities from investigator site qualification, contracting, site management to study closure. Every monitoring plan is tailored to each specific trial.
We understand the importance of continuous quality management and have implemented a Quality Management System that is designed to meet the requirements of the international standard ICH Q10 Pharmaceutical Quality System.
Our Quality Management System is put into practice by
- Quality Manual Handbook (QMS outline)
- Quality Manual (SOPs and other controlled documents)
- Quality Objectives
- Corrective and Preventive Actions System
- Internal Audit and Compliance
- Vendor Quality Assessments
- Change Management Procedures
- Continuous Improvement Efforts following External Audits & Inspections
- Quality Management Department (independent reporting line)
Partner with CR2O to tap into our accumulated experience of 400 studies in over 30 countries. From protocol development to clinical monitoring, we are here for you every step of the way.
BIOSTATISTICS AND DATA MANAGEMENT
Data quality influences the outcome of your clinical trial. CR2O provides clinical data management solutions to ensure data is complete, valid and reliable. Our Biostaticians analyze, evaluate and interpret data gathered. Being involved in ongoing processes to improve the quality of scientific inference, they are experts in transforming data to knowledge.
A team of medical and pharmacovigilance experts performs data entry, data review and medical review. We have managed clinical safety assignments (phase I-IV) across various therapeutic indications.
Clinical trials are subject to strict regulations; therefore it is of utmost importance to provide standard-compliant documents. Our medial writers are experienced in authoring and designing well-structured documents in compliance with ICH Guidelines and regulatory requirements. Medical writing services include expert report, investigator brochure, trial protocol, patient safety narratives, statistical analysis report, clinical trial report.
CR2O possesses the qualified work force for when you need to increase your staff size for a determined period of time. We offer efficient and integrated solutions to your staffing needs within the clinical trials market. We are proud of our life science professionals, particularly experts in clinical development. Our Insourcing services brings you advantage in global know-how, international contacts and flexibility.
You will have access to the right experts for your clinical trials.
- Trained life sciences professionals
- Individuals or teams
- Flexible contract durations
- Flexible staffing models
- Flexible staff locations
- Diverse backgrounds and expertise