CW-Research & Management is a contract research organisation (CRO) that provides high-quality clinical operations and management services for pharmaceutical, biotechnological, medical devices and healthcare companies.
The company is certified according to EN ISO 9001: 2015 and it utilises more than 25 years’ experience to efficiently manage client’s medical device and drug development projects.
Operations management for clinical and non-interventional studies
CW-Research & Management provides support throughout the entire development cycle of clinical and non-interventional studies (NIS) such as post-authorisation safety studies (PASS), post-marketing observational studies (PMOS) and registries for pharmaceutical products and medical devices.
The firm provides assistance starting in the earliest planning phase and ranging throughout the study, to data evaluation and project closure.
Its wide range of services includes advice on study design and statistics, preparation of study documents, submission to ethics committees and regulatory authorities, site selection, site feasibility and maintenance of trial master files (TMF), as well as on-site training, organisation of investigator meetings, quality assurance (QA), monitoring, project management, data entry and study reports.
Clinical trial data collection and management
CW-Research & Management aims to optimise quality control and data management in clinical trials to ensure companies maintain adherence with a continuously growing amount of legal requirements.
The company collects and manages clinical study or safety data using either an in-house electronic case report form (eCRF) or by manually importing paper-based documentation to a custom database for subsequent statistical analysis. This follows the creation of data management and validation plans.
Biometrics and coding for clinical trial data
CW-Research & Management utilises statistical methods to efficiently draw conclusions from clinical trial data.
A prerequisite for the electronic data exchange with regulatory authorities is the use of a coding system. The firm offers coding in accordance with Medical Dictionary for Regulatory Activities (MedDRA), Anatomical Therapeutic Chemical (ATC) classification and the World Health Organisation (WHO) standards.
Medical writing editorial services
CW-Research & Management works closely with clients to ensure their scientific and medical texts show a clear and well-structured working method.
The firm’s medical writing service provides support with study document creation such as protocols, observation plans, information leaflets, patient diaries and clinical study reports.
CW-Research & Management also prepares publication manuscripts, meeting abstracts, posters and training documents.
Pharmacovigilance and drug safety services for developers
CW-Research & Management’s pharmacovigilance services help to optimise drug safety during clinical trials but also throughout the entire lifecycle of a medicinal product or medical device.
The firm ensures drug developers and clinical trials meet new legislations that consistently demand more from pharmaceutical companies.
Quality assurance and auditing for clinical studies
CW-Research & Management evaluates the quality of work and the effectiveness of a quality management system by conducting regular audits.
The company offers a wide range of quality assurance and auditing services, including:
- Conduct of good clinical practice (GCP), good distribution practice (GDP) and good manufacturing practice (GMP) audits of sites, laboratories, sponsors and CROs
- Preparation for upcoming inspections or external audits
- QA through GCP training, co-monitoring, or compliance visits
Quality and risk management in the healthcare sector
CW-Research & Management establishes, implements, maintains and improves custom quality and risk management systems in the healthcare sector to help companies remain competitive.
Custom solutions for drug and medical device development
As each project is different, CW-Research & Management provides customised solutions to match the client’s objectives and requirements.
The firm’s diverse and flexible service portfolio comprises all-inclusive concepts and also individual services.
About CW-Research & Management
Founded in 1993 in Austria, the combination of CW-Research & Management’s expertise and 25 years’ experience is the basis of its corporate philosophy.
The firm has established a network of cooperation partners and works closely together with Phase I–IV sites and a central laboratory.
Its offices are located in Austria and Germany.