Clinical Trial Management

IRW offers phase I-IV pharmaceutical trial management, as well as all classes of medical device investigations, from single-centre to multi-national projects.

With more than ten years experience of working with several indications and products, our competent, dedicated and flexible study teams are ready and able to deliver. We manage projects from start to finish, but are also happy to work as an integrated part of your own study team.

The dedicated and professional IRW staff offers a wide range of academic competence and solid experience of clinical research, as well as of working with global pharmaceutical and biotech companies, and of interacting with the various regulatory authorities in the Nordic region. All our staff have medical/scientific backgrounds and continuously undergo documented training. In order to be able to work efficiently within various EDC Systems, keeping up with the latest technology developments is a training priority.

Services:

• Project management
• Medical writing
• Regulatory and ethics committee submissions and contacts
• Feasibility and patient recruitment
• Clinical monitoring and site management

Project management

Comprehensive project management is the key to the success of any study. We have teams of experienced and well-educated project managers present in all Nordic countries. Our project managers maintain an overview of all aspects of the study, working closely with the study team to ensure control of project scope, quality, budget and timeline.

Medical writing

Our medical writers work closely with our statisticians, medical advisers and, of course, sponsors. All in order to develop study protocols, clinical investigation plans and reports in accordance with current regulations and guidelines. They also collaborate with the project team, and participate interactively throughout the study, from protocol to final study report.

Regulatory and ethics committee submissions and contacts

We have many years’ experience of handling the regulatory and ethics committee submissions and contacts in all the Nordic countries, using our local experts. This includes local mandatory regulations, such as Biobank agreements, Personal Data Act requirements and Radiation Committees regulations. Our familiarity with local ethics and regulatory requirements is invaluable in reducing approval process timelines.

Feasibility and patient recruitment

Slow patient recruitment is by far the most common cause of delays in clinical studies. Being a local Nordic CRO, our wide-ranging local networks include investigators both in the private sector and within the public healthcare system. We use a well-defined process when selecting sites, using study-specific questionnaires, thorough feasibility assessment and painstaking evaluation of the potential sites; all to ensure a high probability of reaching the required number of patients for the study within the specified timeline.

Clinical monitoring and site management

All Nordic IRW offices offer highly experienced Clinical Research Associates (CRA), fluent in English as well as the local language. Our project teams collaborate closely with our sponsors, and maintain close contact with the sites, supporting each investigator in order to maximise quality and performance. Study sites in all Nordic countries are within easy reach of our CRAs, facilitating coordination and operational efficiency.

Studies are carried out according to current regulations and guidelines. Additionally, ICH-GCP, local ethical requirements and Sponsor or IRW SOPs as well as all procedures and data collected are subject to our in-house Quality Assurance.