Clinical trials should be planned and performed by qualified personnel at all levels; sponsor, vendors and sites. Clinical trials must be carefully planned and conducted in accordance with industry, international and local regulations.
Choosing the optimal EDC platform for your clinical trial
The use of Electronic Data Capture (EDC) and Electronic Case Report Forms (eCRFs) has become the gold standard in clinical research.
As a result the market has become flooded with EDC vendors of varying levels of functionality and quality
As part of TechnoSTAT’s one-stop-shop resource for data management and statistical services, TechnoSTAT is proud to provide complete state-of-the-art services to meet CDISC compliance.
It may go without saying that we design our clinical trials in a manner that will achieve our objectives while requiring the least amount of resources. It is less obvious just how well statistics can help us do it.
In recent years sponsors invest greater efforts than ever to cut monitoring expenses using the emergence of new technological solutions and by designing different monitoring modalities to perform monitoring activities in the most cost effective way but with no damage to quality.
Virtually all late-stage trials—and certainly pivotal trials—are confirmatory in the sense that hypotheses are formulated in the protocol and tested using the data subsequently obtained in the trial.