Experiences
With an extensive experience spanning over 25 years, we have honed our proficiency in establishing a wide range of projects, from uncomplicated uni-directional Adherence programs to intricate eClinical Research Programs.
Our service portfolio caters to clients of all sizes, encompassing both small-scale ventures and large international projects. We boast an impressive track record, having successfully executed over 80 Medical/Clinical Programs across more than 34 countries, with our systems actively utilized by over 30,000 patients worldwide.
Here are some noteworthy success stories from our consulting services:
eClinical validation for a global pharmaceutical major.
Part 11 remediation for a global pharmaceutical major.
LIMS validation at a major global pharmaceutical company.
Legacy IT Compliance remediation at a prominent global Medical Device enterprise.
Software validation for a major player in the Medical Device industry.
IT Infrastructure / Data Center Qualification for a leading global pharmaceutical company.
GxP compliant cloud implementation for a renowned global pharmaceutical major.
Establishment of a certified training program for eClinical Experts.
Registration of various medical devices in Europe and the US.
Participation in governmental expert panels.
Advisory role for the boards of lifesciences technology companies.
Revitalization of a Healthcare Business Unit for a top European IT company (+ 8.000 employees)
Portfolio management and regulatory compliance management of a Healthcare service provider
Regulatory and quality compliance for a SaMD manufacturer
One notable instance involves rejuvenating a Healthcare Business Unit. We were entrusted with analyzing and devising a plan to enhance its profitability and viability. This project reached break-even in just six months and achieved profitability within the first year. By the second year, the EBIT saw a remarkable surge, reaching 35%, alongside an impressive annual revenue increase of 30%.
Another success story involves setting up a Clinical Recruiting branch for a staffing agency. In response to their aim to diversify into lifescience industries, we assisted in building their team, providing comprehensive training on interacting with professionals like medical directors and research directors. This initiative led to the placement of 47 candidates in pivotal roles during the inaugural year. Ultimately, the branch's success led to its acquisition by a larger recruiting firm, Randstad.
These stories epitomize our commitment to achieving tangible and transformative results for our clients across various domains within the lifesciences and healthcare sectors.
We also have won prizes and received grants for our Products:
Eur J Prev Cardiol. 2015 Aug 19. pii: 2047487315602257. - Effect of comprehensive cardiac telerehabilitation on one-year cardiovascular rehospitalization rate, medical costs and quality of life: A cost-effectiveness analysis. http://www.ncbi.nlm.nih.gov/pubmed/26289723
Eur J Prev Cardiol. 2015 Feb;22(2):150-8. doi: 10.1177/2047487313514018. Epub 2013 Nov 18. - Increasing the medium-term clinical benefits of hospital-based cardiac rehabilitation by physical activity telemonitoring in coronary artery disease patients. http://www.ncbi.nlm.nih.gov/pubmed/24249840
J Med Internet Res. 2015 Jul 23;17(7):e185. doi: 10.2196/jmir.4799. - Medium-Term Effectiveness of a Comprehensive Internet-Based and Patient-Specific Telerehabilitation Program With Text Messaging Support for Cardiac Patients: Randomized Controlled Trial. http://www.ncbi.nlm.nih.gov/pubmed/26206311
BMC Cardiovasc Disord. 2015 May 7;15:29. doi: 10.1186/s12872-015-0021-5. - Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design. http://www.ncbi.nlm.nih.gov/pubmed/25948479
Agoria (Belgian industry) award for best health, telehealth and telecare project in 2012