DATA MANAGEMENT
Established in 2010, 26 + studies to date
Therapeutic Areas of experience include:
Services Include:
CRF DESIGN
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.
DATABASE DESIGN
A Database Design involves the annotation of CRFs (aCRF) 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 is done according to the user’s specifications, the trial protocol, and the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Guidelines. TASK has database, data programmers, and administrators that offer database design in Clinical Database Management Systems (CDMS).
DATABASE VALIDATION
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 MANAGEMENT PLAN
A data management plan (DMP) outlines the plan for how the data during the life cycle of the clinical trial will be handled and processed in the Clinical Database Management Systems (CDMS). TASK has data managers who draft the DMP according to the protocol, sponsor requirements, and database design. TASK data managers also oversee the clinical trial in the CDMS to ensure that the DMP is adhered to. This includes a complete audit trail of all authorisations and activities which are stored in the study data Clinical Trial Master File.
DATA ENTRY
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.
DATA CLEANING
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. Data reconciliation is also conducted for data from different sources such as laboratory data and site sample information to ensure data sources are consistent.
PHARMACOVIGILANCE
Pharmacovigilance (PV) is a science related to the assessment and monitoring of safety data during the clinical trial to ensure understanding and prevention of adverse effects or medicine-related problems., TASK DM offers PV data listings which come integrated with Safet tables for individual participant and treatment group analysis. The PV data listings are designed according to ICH E9 and sponsor requirements. PV data listings are provided continuously with a short turn around time to ensure PV is done with the most updated study data.
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. TASK DM follows the CDISC SDTM standard when transferring data.
STATISTICAL ANALYSIS PLAN
The Statistical Analysis Plan(SAP) is a document that describes the statistical analysis methods that will be used to answer the objectives of the clinical trial. TASK DM has statistical programmers and a statistician who drafts the SAP based on the protocol and ICH E3 guidelines.
STATISTICAL ANALYSIS
This process involves programming and reporting according to the Statistical Analysis Plan, ICH E3, and E9 guidelines. TASK DM has statistical programmers and a statistician to generate the tables, listings, and figures to answer the research question. We also provide Safety, Demographics, Palatability, and Tolerability statistical analysis reports for clinical trials designed for inclusion in the Clinical Study Report (CSR). TASK DM has major experience in Safety and Efficacy analysis. If a sponsor has their preferred Trial Statistician, TASK DM can program and provide the Safety, PK, and Efficacy analysis datasets from the clinical trial data (SDTM datasets).
