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IRW

Full-Service Nordic Clinical Research Organisation (CRO)

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IRW

IRW is a Nordic full-service Clinical Research Organisation (CRO) with more than ten years experience and local offices in Sweden, Denmark, Finland and Norway. We offer solid know-how and experience of clinical research, data management, biostatistics and pharmacovigilance for global and small pharma, biotech and the medical devices industry.

IRW are experts in interacting with Nordic regulatory authorities. We cover the full range of CRO services throughout your products’ lifecycle, for studies of all sizes and through all phases and beyond, acting either as a full-responsibility partner or provider of in-sourced expertise.

The IRW team is dedicated and professional, with 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.

Clinical trial management, data management, biostatistics and pharmacovigilance services

We cover the full range from single-centre to multi-national projects, offering professional clinical trial management, data management, biostatistics and pharmacovigilance services for pharmaceutical, biotechnology and medical device companies. We can manage your project from start to finish, or function as a fully-integrated part of your study team.

At IRW, we are aware of the fact that our customers need to cut timelines and be cost-effective when bringing an investigational product up to registration. In all Nordic countries, we have experienced native-speaking experts handling all regulatory and ethical submissions, as well as local monitoring services and support-to-site. This, together with an excellent network of local investigators, will speed up the regulatory processes, as well as facilitating communications with sites and investigators.

We conduct all our work according to current regulations and guidelines i.e. ICH-GCP, local ethical requirements, the Helsinki Declaration and Sponsor or IRW SOPs. All our procedures and data collected are subject to our in-house Quality Assurance.

Being a local Nordic CRO, we can provide you with our wide-ranging knowledge on local networks, including investigators, both within the private sector and in state-run institutions.

info@irwcro.com
www.irwcro.com

Sweden / Head Office
IRW Consulting AB
Box 130 78
Kungsgatan 64
103 02 STOCKHOLM
Tel: +46 (0)8 791 66 40
Fax: +46 (0)8 758 90 56
Denmark
IRW Consulting in Copenhagen
Lyngsø Allé 3C
Bygning 26
DK-2970 HØRSHOLM
Tel:+45 45 79 01 02
Fax: +45 45 79 01 04
Norway
IRW Consulting in Oslo
Strandveien 50
NO-1324 LYSAKER
Tel: +47 (0)67 58 28 88
Fax: +47 (0)67 58 28 89
Finalnd
IRW Consulting in Helsinki
Rajatorpantie 41 C
SF-01640 VANTAA
Tel: +358 (0)9 8520 2700
Fax: +358 (0)9 8520 2702

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…

Data Management

Our tools are extensively customised to meet your specific needs – both for paper-based and Electronic Data Capture (EDC) trials. Our systems, SOPs and staff will provide you with cost-effective, secure, regulatory-compliant and efficient data management services.

Efficient data management speeds the clinical trial process and ensures excellent data collection accuracy and consistency. We can meet all of your clinical data management needs. Services: Selection of appropriate technology and processes for your study Case report forms (CRF) Design and database implementation Electronic Data Capture (EDC) ePro/eDiary systems Data validation and clinical programming…

Outsourcing

IRW is aware of the need of many life science companies for urgent short-term and long-term staffing, due to unexpected workload variations.

Our pan-Nordic presence, with offices and local staff in Denmark, Finland, Norway and Sweden offers our customers the option of insourcing experienced, qualified and flexible resources within clinical operations, data management and pharmacovigilance, in order to: Bridge an acute temporary shortage of experienced staff Maintain projects when freeze on headcount is in place Manage the…
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