Clinical Trial Management Software TermsThe following are the common terms used in clinical trials: ARM: Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more. CLINICAL INVESTIGATOR: A medical researcher in charge of carrying out a clinical trial's protocol.CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. ELIGIBILITY CRITERIA: Summary criteria for participant selection; includes Inclusion and Exclusion criteria.ENROLLING: The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process. INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. INSTITUTIONAL REVIEW BOARD (IRB): A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. RANDOMIZED TRIAL: A study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized. STUDY TYPE: The primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing.Clinical CTMS & EDC
Octalsoft CTMS (Clinical Trials Management System) and EDC (Electronic Data Capture) provides a single, centralized system to manage sponsor and Clinical Research Organization (CRO) study management activities. Sponsors including biotechnology, pharmaceutical, and medical device companies as well as CROs can efficiently manage the complexities of large clinical trials using our CTMS. Octalsoft CTMS & EDC users benefit from sharing consistent clinical trial data across the entire enterprise and both CROs & sponsor organizations get direct insight into various phases through the study life cycle. Octalsoft clinical data management capabilities assist in producing results that are accurate, accessible, reproducible and cost-efficient. |
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