The critical stage of every clinical development program requires careful planning and professional performance.
CTNT team has extensive experience in early clinical development stages when new compounds, medical devices and technologies must be tested for safety, tolerability and efficacy in humans.
Our team has the expertise to help you meet all the requirements of your clinical development process. According to your program’s development phase we will design the essential documents : from first-in-man (FIM) phase I studies to post-marketing studies, from feasibility to pivotal studies as well as non-interventional programs.
We will identify the right sites and investigators and conduct the optimal feasibility and site selection process for you.
We will then manage all aspects of your clinical trial, including monitoring, data cleaning, quality assurance, and writing of clinical study reports and summaries for submission to the regulatory and health authorities.
Our services include:
Development of study protocol, investigator’s brochure, informed consent form and other regulatory documents
Preparation of case report forms (CRFs), worksheets, questionnaires, study-specific forms and patient tools
Site identification and selection
Evaluation and selection of study vendors (central laboratory, imaging etc.)
Ethics committee and competent authority regulatory submissions
Investigator contract negotiation
Investigator meeting preparation
Study coordination and site support
Training of study staff and collaboration with other cooperating units