Services: Clinical Project Management, Staffing Solutions, Feasibility, Site Selection, Regulatory Affairs, Clinical Trials Monitoring, Medical Monitoring, Pharmacovigilance, Data Management & Statistics, Quality Assurance, Logistics, Drug Management, Medical Writing
Locations: Italy, Belgium, Poland, Russia, Ukraine, Germany, Netherlands, United Kingdom, Spain, United States of America. Through these subsidiaries and company staff located in many other European countries, CROMSOURCE provides an established infrastructure through which it is active across the whole of Europe and the USA.
Description: For nearly 20 years, CROMSOURCE (a full-service CRO) has been conducting clinical development programmes across Western, Central and Eastern Europe. The depth of our experience in Central and Eastern Europe in particular is unusual and ensures our Sponsors receive the maximum possible benefit when including this region in their clinical research programmes. CROMSOURCE provides a wide range of clinical research services and staffing solutions to the pharmaceutical, biotechnology, vaccine and medical device industries and works across all therapeutic areas including but not limited to oncology, respiratory, cardiovascular, metabolic, HIV, CNS, vaccines, and dermatology. CROMSOURCE has notable experience in medical device trials, having conducted a large number of clinical investigations in a range of CAT II and CAT III devices.
Whilst CROMSOURCE routinely works with many of the largest multinational pharmaceutical companies, it remains a mid-sized organisation and offers an adaptable structure to its sponsors who quickly establish direct contacts with the project team, including senior management. This approach is appreciated particularly by our sponsors in the Biotechnology and Small to Mid-sized Pharma sectors.
The CROMSOURCE proactive approach includes ‘Quality by Design' – ensuring all aspects of operations are closely managed, including those of each single project, with a view to proactively identify and prevent quality issues and operational threats rather than relying solely on the ability to react to issues when they arise.
Quality management and quality assurance are kept under constant review and are assiduously implemented by CROMSOURCE. Quality assurance is guaranteed through the integrated, certified quality system ISO 9001 first achieved in 2002 when few competitor companies had considered such accreditation important. The quality system is revised quarterly and thoroughly reviewed every two years by an external and independent auditor.
Feasibility Plus is an extremely detailed feasibility analysis performed by our dedicated Feasibility Unit and which involves direct contact with potential investigators. Feasibility Plus provides accurate country and site selection data, and allows precise budget and timeline forecasts. Feasibility Plus is provided free and without obligation at the proposal stage. It is part of our commitment to provide accurate information to our potential sponsors.
ONE TRIAL ONE PRICE
CROMSOURCE believes that traditional CRO contracts based on time and materials can lead to a misalignment of sponsor and CRO goals, and reward CRO inefficiency and delays. As experts in the organisation, management and delivery of clinical research, CROMSOURCE offers One Trial One Price. Put simply, this is our pledge that the price agreed at contract signature is the final price that the Sponsor will pay. In this way, CROMSOURCE provides our sponsors with a concrete budget and contrasts markedly with the change order culture of many other CROs.
EXPERT TRIAL RESCUE
In recent years CROMSOURCE has undertaken many rescue projects for Sponsors dissatisfied with the performance of the originally selected CRO or by the level of subject recruitment from the sites selected. Such projects are handled by a dedicated Rescue Project team who quickly assess the situation and provide detailed recommendations to the Sponsor in order to get such trials back on track.
Since our inception CROMSOURCE has been providing innovative, flexible staffing solutions to clients in both the Pharmaceutical and Medical Device fields. We have experience in functional service provider relationships, and in providing high quality interim, long term and permanent staff in over 20 countries.
Perhaps the most pertinent indicator of the level of satisfaction experienced by Sponsors who choose to work with CROMSOURCE is the high number of Sponsors who return to CROMSOURCE with their projects time and again. The company is proud of this level of repeat business (over 80%) and feels that this demonstrates that CROMSOURCE is a reliable partner who delivers high quality projects on time and on budget. We hope that this encourages you to find out more about us.
Clinical Trial Design, Clinical Trial Monitoring, Data Management, Investigational Site/Network, Medical Writing, Pharmacovigilance, Project Management, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy, Statistical Services/Meta Analysis