Consulting Success Stories
• Part 11 remediation for a global Pharma major
• eClinical validation at a global Pharma major
• LIMS validation at a global Pharma major
• Legacy IT Compliance remediation at a global Medical Device company
• Software validation for a Medical Device major
• IT Infrastructure / Data Center Qualification for a global Pharma company
• GxP compliant cloud implementation for a global Pharma major
• Setup a certified training program for eClinical Experts
Revitalize a business unit
This client requested us to analyze his business unit Healthcare and come up with a plan to make it profitable and if possible give it a future. The project got break-even after 6 months and was profitable after the first year. After the second year the EBIT peaked at 35% with a overall revenue increase of 30% per year.
Setup a clinical recruiting branch for a staffing agency
We were approached by a staffing agency to help them diversify in other industries, especially the lifescience area. We helped built their team and trained the individuals on the basics required to face various lifescience professionals like a medical director or research director. The company grew steadily by placing 47 candidates during the first year in leading roles. The branch was finally sold to a bigger recruiting firm - Randstad.
Online HealtheCoaching system
Yorbody (yorbody.com) is a non-invasive patient monitoring and lifestyle coaching solution, an unique system that's been designed to help patients achieve their weight, fitness and health goals within their everyday routine.
Grants, publications and prizes:
First clinical trial - Telerehab II: A multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design Project description (Eur J Prev Cardiol. 2015 Feb;22(2):150-8. doi: 10.1177/2047487313514018. Epub 2013 Nov 18), publication
Agoria industry award (Belgian federation of technology) - award for best telehealth, telecare and ehealth project in 2012: Press
Flanders Care grant - Telerehab III: A multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study designProject description (BMC Cardiovasc Disord. 2015 May 7;15:29. doi: 10.1186/s12872-015-0021-5), project slides, project clip
Setup eClinical Provider
We founded in 2005 the company and got a corporate investor in 2007 helping us grow. We provided solutions to pharmaceutical and biotech clients on a “customised solutions per study” basis with a clinical approach. The company has grown into a multi-national company with offices in Belgium, India, Germany and the USA.
EDC; CTMS; CDMS; Patient Diaries; eCTD; Clinical Trials; Compliance; ePRO (Electronic Patient Reported Outcomes); Electronic Medical Records (EMR); Patient Tracking; R & D; Phase I, Phase II, Phase III, Phase IV; eCRF, supply mgt, randomization, medical coding.
The company was sold to Aris Global.