Established in 2010 | Number of studies to date = 26+
Therapeutic Areas of experience include:
. Tuberculosis – 20 + trials
. Oncology – 3 trials
. Crohn’s Disease – 2 trials
. COVID/BCG – 1 trial
A Case Report Form (CRF) is designed to collect the data in a clinical trial, in line with the study protocol and CDISC standards. TASK DM offers this service for both paper and electronic based CRFs.
A Database Design involves the annotation of CRFs and the development of the structure and system where CRF information collected during the clinical trial is stored and integrated. The annotation of CRFs and database development are done according to the user’s specifications and the Clinical Data Interchange Standards Consortium
(CDISC) Study Data Tabulation Model (SDTM) Guidelines. TASK has data programmers that offer database design in Clindex.
Database validation ensures the e/CRF is reflected in the database. Validation of rules/checks, referred to as Edit specifications, are programmed into the database to ensure accurate data, this is done by testing all possible scenarios with test cases. An integral part of the validation process is User Acceptance testing, to ensure that all applicable functions are tested for each user profile before the database goes into production.
Data entry into the Database can be done either centralised by TASK DM or with the support of site staff who are provided with the appropriate training and eCRF completion guidelines.
Cleaning is conducted through edit specifications, system generated queries and manual reviews. Queries raised are then resolved through a data clarification reporting and review process.
DATABASE LOCK & TRANSFER
Clinical trial data is not only sensitive, but its integrity must also be maintained. TASK DM follows strict international guidelines in locking study data and transferring data, as well as following the sponsor’s request.
This process involves programming according to the Statistical Analysis Plan. TASK DM has statistical programmers to generate the tables, listings and figures to answer the research question.
The process of using statistical modelling based on pharmacology (pharmacokinetic and pharmacodynamics), physiology and pathophysiology to analyse interactions between drugs and patients, models can be used to predict clinical or pharmacokinetic outcomes. PMX is a powerful tool in efficient, evidence-based drug development and
may guide regulatory decisions.