CRS is qualified for excellent support
CRS has all it takes to successfully conduct first-in-human clinical trials
The safety and well-being of all trial subjects is always of primary importance for CRS. Along with that we are ready and well prepared to support our clients
- with the CRS power to recruit perfectly suitable subjects for your FiH trial,
- with our highly experienced in-house physicians and staff to conduct your trial safely, and
- with the ability to quickly and efficiently meet deadlines.
As appropriate and agreed with the client, CRS starts FiH studies with a single dose trial and follows on with multiple dose trials and food effect studies.
Over the last five years CRS has successfully performed more than 850 clinical trials. About 5 percent of them were FiH trials.
First-in-human: what is it all about?
According to the European Medicines Agency´s (EMA) “Guideline on strategies to identify and mitigate risk for first-in-human and early clinical trials with investigational medicinal products –– The purpose of FiH trials is to evaluate an investigational medicinal product (IMP) in human first time, to study the human pharmacology, tolerability and safety of the IMP and effects seen in non-clinical studies translate into humans.“
Hence, CRS’ objectives strictly support this: to investigate the pharmacokinetic (PK), pharmacodynamic (PD), the safety and tolerability and also to gain early information on all effects of the IMP on humans.
Studying all IMP effects carefully is essential for the early detection and characterization of any risk related to the new drug and for the implementation of appropriate strategies for risk mitigation.
CRS PROVIDES FULL SAFETY DATA WITHIN SHORTEST TIME
CRS strictly supports all recommendations, rules, and guidelines of competent authorities related to FiH clinical trials. During such trials we maintain close contact with our clients. And we are able to provide full safety data for the dose escalation within shortest time. Thus we quickly release crucial data for our clients’ further decision-making.
• Single Ascending Dose (SAD) & Multiple Ascending Dose (MAD) trials
• Combined protocols: SAD/MAD + food + Proof of Concept (POC) trials.
CRS embraces the notion that clarity and simplicity lead to good decisions. We take complex PK principles and make them understandable and usable for common sense drug development. Many of our PK consultants have 15 to 30 years of industry experience. They conduct highly sophisticated analyses in a fully validated computing environment with the latest PK modeling software.