Phase I-III Clinical Research Services
At ethica CRO, we provide a complete range of clinical study management and biometrics services for clinical research phases I through IV. On this page we will lay out the extent of the services we offer for:
Phase I human pharmacology trials
Phase II therapeutic exploratory trials
Phase III therapeutic confirmatory trials
Do you want to find out more about how our study management services can benefit your Phase I, II, or III study?
Our Phase I Clinical Study Services
Although ethica CRO does not have in-house facilities designed for the conduct of Phase I research, our team is highly skilled in the placement and management of such studies at dedicated clinical pharmacology units. These facilities have been pre-qualified based on our accredited standard operating procedures (SOPs) and are specialized for early-phase clinical trials. We understand that selecting the proper Phase I facility for your study can be challenging, which is why our clinical management team will help you with:
Manage the request for proposal (RFP) process to obtain consistent proposals among prospective facilities.
Assess the prospective facilities’ resources, staffing, training, education and experience.
Ensure cost-effectiveness throughout the study and accelerate the delivery of trial results
Our Research Participant-Centric Approach
At ethica CRO, it is our priority to ensure that our early phase clinical research services are delivered according to the highest standards of ethical and clinical practices and that the rights and welfare of research participants are constantly safeguarded throughout each clinical study phase.
Our Phase II and III Clinical Study Services
We understand that efficient medical monitoring and delineation of safety profiles are key to your Phase II study success. Our medical monitoring team is composed of a network of specialist physicians who will guide your research staff through the wide range of issues that your clinical study might face. In parallel, we will provide all necessary statistical support to conduct interim analyses and generate Data Safety Monitoring Board (DSMB) status reports.
Beyond ethica CRO’s ample experience in the development and management of Phase II and III programs, we are also adept in the conceptualization of proof-of-concept (POC) studies. Our full range of services are aimed to establish the safety, efficacy, and dose information that is required to effectively move your drug or biologic down the pathway towards approval.
Likewise, for your Phase III program, our experienced clinical management team will put in place strong site management and enrollment strategies. We will also oversee all medical monitoring activities to ensure that the large volume of sites, participants, and data are properly managed and collectively lead to your desired outcome.
Once your Phase I, II, or III study is launched, ethica CRO will provide appropriate supervision and monitoring to ensure that study conduct is consistent with good clinical practice and other relevant research standards, delivering trustworthy and timely results.