Study History Overview
A successful clinical development program in Endocrinology and Diabetes must take into account the evolving global regulatory requirements in this therapy area. The trend is for longer, more complex trials which further increase budget and timeline challenges.
With offices throughout the US and Europe, and deep recent experience (50+ studies, 50,000+ patients and 12,000 sites in the past 5 years in Type I Diabetes alone) CROMSOURCE is well positioned to make your study a solid success.
Over the years we have developed close relationships with Endocrinology experts and Key Opinion Leaders and created a trusted network of high-quality endocrinology research sites across Europe and North America. We are also experts in the management of third party vendors such as central laboratories, whose importance in delivering endpoint data for these trials is considerable.
CROMSOURCE's Endocrinology and Diabetes experience in the last 5 years includes over 60 studies with medicinal products in thousands of patients in Phase 1 through Registry and with Medical Devices at Pilot and Pivotal study stages. Studies in both of these areas have been performed across Europe and North America.
We have completed studies in a wide range of conditions including but not limited to Hyperparathyroidism, Type I Diabetes, Type IIDiabetes and Obesity. Significantly we have completed several studies including pediatric subjects. Through our endocrinology expertise, CROMSOURCE adds i mmediate value to your project.
Identify Countries & Sites for Maximum Enrollment and Retention
CROMSOURCE has developed a stringent methodology to help sponsors identify the highest enrolling countries and sites during the Feasibility stage. Our unique Feasibility PIusTM approach is provided to potential clients without obligation at the RFP stage and is the foundation of our ability to offer sponsors a guaranteed timeline, enrollment and budget.
Working closely with our clients, CROMSOURCE identifies those geographic areas well known for their prevalence of the targeted indication. All regulatory requirements are reviewed and timelines developed for each country to ensure the best regulatory strategy. CROMSOURCE then works directly with the most professional and productive sites in each geography. Sites are only considered if they have proven they can deliver a combination of high enrollment, high retention and quality data.
With the accurate and detailed trial planning data provided by Feasibility PIusTMCROMSOURCE confidently offers Sponsors a comprehensive End- to-End Guarantee, assuring them that their study will be completed on- ti me and on-budget with no CRO initiated changes in scope.
- Endocrinology & Diabetes Expertise and Experience
- Operational Excellence based on 20 years of Experience
- The only "End-to-End Guarantee" in the Industry
- Detailed Knowledge of Sites, Investigators, KOLs
CROMSOURCE guarantees timelines for Study Start Up, Enrollment and Date for Database Lock. Moreover, we guarantee there will be no post-signature, CRO-initiated change orders.
The price agreed upon at contract signing will be the price you will pay.
Our End-to-End Guarantee
- Guaranteed study start-up time
- Guaranteed enrollment
- Guaranteed price with no CRO initiated changes in scope
- Guaranteed database lock date
How can CROMSOURCE do this?
- Realistic and deeply detailed feasibility analysis
- Operational excellence within a cohesive team
- Excellent, long-term relationships with sites, investigators, and KOLs
North American Headquarters
One Alewife Center, Suite 120 Cambridge, MA 02140 - USA
Direct: +1 617 871 1128
Fax: +1 617 871 1129
Via Giorgio De Sandre, 3 37135 Verona - Italy
Direct: +39 045 8222811
Fax: +39 045 8222812
ISO 9001:2008 multi-site certified quality management system
ISO 14155:2011 conformity confirmed
Cloud Media Management
CROMSOURCE, via Techorizon (the CROMSOURCE IT branch) provides a service (GAMP 5 compliant) to support our clients in managing image acquisition, collection, centralized evaluation and archiving. Our Cloud Media Management tool providescentralized capabilities for managing any type of media, including magnetic resonance imaging and computed tomography.
Chief Executive Officer
Client Project Development Director
Antoinette Torres Frankum
Head of US Operations