Phase I-III Clinical Research Services
Bringing expertise and excellence to your Phase I, II, or III clinical study.
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 CRO services can be contracted either as a comprehensive package to manage your entire study or on a selective basis when additional resources and services are required.
ethica CRO also offers support for all classes of medical device investigations, from single-site to multi-centre projects. While we provide “turn-key” solutions to manage projects from start to finish, we can also act as an integrated part of your research team.
Our Phase I Clinical Study Services
Although our biotech 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:
RFP Management
Manage the request for proposal (RFP) process to obtain consistent proposals among prospective facilities.
Site Qualification
Assess the prospective facilities’ resources, staffing, training, education and experience.
Project Management
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 project 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.