Biopharmaceutical CRO Services & Clinical Studies;
In collaboration with our sister company HealthTech Hope and also our Universities partners we offer biopharmaceutical CRO services (from pre-clinical into clinical Phase 1-3) to the pharmaceutical companies and also clinical studies to the medical device industry. We support them in conducting clinical (intervention) studies
These clinical studies fall under the Medical Research Involving Human Subjects Act. Thanks to the collaboration with academic clinical chemistry laboratories, we can offer measuring absorption of active ingredients, as well as effect monitoring on circulating biomarkers and clinical endpoints. Our skilled personnel will execute complete trials or assist you for only those parts where extra support is needed.
We provide professional, customized support regardless of your company’s current phase of business.
Clinical (Intervention) Studies:
Clinical (intervention) studies are controlled research studies testing the health benefit(s) of a new or improved product in human volunteers. Each study starts with its own research questions, which are explained in a study protocol. This protocol describes in detail how the study will be performed and why it is necessary to do it that way. The protocol also describes how the study group is defined, for example based on age, gender, or health status.
- Feasibility analysis
- a study protocol
- contracts (also legal aspects)
- grant proposals
- Budget management
- Medical Ethics Committee (MEC) approval
- In-house execution of projects and supervision
Routine laboratory (according to GLP guidelines):
- Commercial biomarkers are tested in a routine laboratory, in compliance with GLP quality standards to ensure the quality and integrity of the generated data.
- Perform data-entry according to GCP/GLP guidelines
- Perform advanced statistics using the latest version of SPSS software package
- Write interim and final study reports
- Give poster or oral presentations for clients or on scientific meetings
Life Science Business
Flight Forum 40
5657 DB Eindhoven
Tel.: 0031-(0)40-798 3036
Office The Middle East :
Life Science Business
P. O. Box: 122022