Experience, Expertise, Performance in Data Management Services in Clinical Trials
Specialists in data management since 1987, our high level of attention to detail combined with our well developed procedures and common-sense approach across various clinical trials over multiple countries, have earned Datapharm Australia a strong reputation for providing excellence in all data management processes. As information management specialists, we can meet all your data management needs and are able to tailor our services to meet your budget.
Our data management specialists are highly experienced in handling medical and scientific data. All data is thoroughly reviewed by appropriately trained and experienced staff to ensure data integrity. All our data management processes are regulated according to closely controlled SOPs and in accordance with ICH GCP, FDA 21 CFR part 11 and CDISC/CDASH standards. These established data management systems can offer you significant time and cost savings.
Datapharm Australia team takes very seriously its obligation to protect the privacy, confidentiality and security of all information entrusted to us.
Our data management services include:
Case Report Form (CRF) i.e. paper-based CRF or electronic CRF (eCRF)
- Designed by our experienced data management specialists using a well-established CRF library to capture essential data that are important for data analysis depending on each specific trial, protocol and required by regulatory agencies.
Patient diary i.e. paper-based diary or electronic diary (ePRO – electronic patient reported outcomes)
Data capture
- Cater for single, double data entry or scannable forms processing.
- Our data entry operators are fast, accurate, consistently achieving 99.98% accuracy. Our data capture prices are highly competitive.
Database design and development
- Customised database design & maintenance in various systems according to the specific project requirements following ICH GCP, 21 CFR part 11 and CDISC/CDASH standards.
- Enterprise level backup and data migration.
- Data extraction, conversions and archiving in multiple formats e.g. csv, SAS, excel, pdf etc. ready to be imported into any database or analysis software.
Data validation/cleaning
- Our comprehensive study-specific data validation plan (DVP) and data management plan (DMP) are written based on international data management standards. Logic checks based on the DMP and DVP are programmed in SAS and run on batches of data for data cleaning.
- Data queries can arise from manual clarification, data entry queries, electronic plausibility checks or review of data listings.
- Prior to declaration of clean file and database lock, the database will be checked for consistency with the CRFs (QC) on 100% of the primary efficacy variable and 10% random checks of all other variables.
Project/Data management tracking reports
- Any type of tracking reports can be produced and sent as regularly as required. Our highly trained project managers will manage each phase of your project to deliver superior results, on time and at an affordable price.
Data listings
- Regular updates of data listings can be produced so that a snapshot of the data can be viewed as required.
- Data quality control (QC) is conducted in-house after each process to maintain data integrity and consistency.
Data coding
- MedDRA coding: coding of adverse events and medical history in the latest version of MedDRA by certified MedDRA coders with medical background.
- WHO DD coding: coding of medications in WHO DD by experienced coders with medical and pharmaceutical background.