We are using the data management software system called DFdiscover which is developed and licensed by DF/Net Research, Inc. in Seattle, WA. DFdiscover is a hybrid data management system which can support data collection by Electronic Data Capture (EDC), electronic sources and paper (faxed, scanned, emailed) interchangeable. The software is simple and easy-to-use. Data collection can be performed on multiple platforms (desktop, tablet, web browser). Paper CRFs can be completed, scanned and securely transmitted to BIOPHICS where they are received and processed by DFdiscover and the data management team. The power of Intelligent Character Recognition (ICR) software for paper studies reduces data entry time, and a one-to-one relationship of CRF image and data entry screen makes data review intuitive. Entire subject binders directly linked to the data are readily available for review at any time by authorized study personnel. DFdiscover CRF-based studies combine the simplicity of paper with the efficiency of EDC data entry. DFdiscover is fully EDC-capable as well. Sites can enter data quickly and efficiently, with interactive quality control checks in place, directly into the database using either the local application or web-based tools. DFdiscover is 21 CFR Part 11 compliant and its use has been fully validated and documented to FDA standards. Data queries are reduced by DFdiscover’s powerful edit check features. Sites know which form to enter when, and are reminded when forms and visits are overdue. The quality control process doesn’t stop at data entry – all data are reviewed for completeness and accuracy at the data management team.
For users that need ultimate control, power, flexibility and access to the full suite of DFdiscover tools, 64-bit desktop client applications are available for:
• Windows 10
• macOS 10.14 or later
BIOPHICS can provide MedDRA coding of adverse events, medical history, and other medical terms as needed, as a service integrated into the data management of your study. We fully follows MedDRA standards to meet your goals of harmonizing data. BIOPHICS also subscribes to the WHODrug Global dictionary to provide our clients with the industry-standard in drug coding. We can provide WHODrug coding of your concomitant or other medications.
Our statisticians have expertise in Statistical Analysis Software (SAS). We are using SAS as the main program for data analysis. It is an effective program in data management and can convert data from other statistical programs to SAS dataset including TEXT files. We are also skilled with other statistical software packages including R, Stata and SPSS.
Our statisticians have more than 10 years of experience in performing statistical analysis for all range of study design including clinical trials (phase I to phase III) with or without intervention, cohort study, and survey etc.
Randomization is one of the statistical services we provide at BIOPHICS. The randomization is done by designated unblinded statistician. We work with the investigator to design Randomization schema e.g. block design, stratification design and other schemes that is suitable for the research project. Randomization is performed using SAS program. We also provide randomization in the interactive web response system (IWRS).
When the study is completed, the study data can be transferred in TEXT, Excel, or SAS dataset, as well as in other statistical programming formats as required by our clients.
Yes, we have quality management system with Standard Operating Procedures (SOPs), Forms, and Work Practice Documents for all steps of our work.
BIOPHICS is working in compliance with:
• Good Clinical Practice (GCP)
• Good Clinical Data Management Practice (GCDMP)
• US FDA 21 CFR Part 11
Yes, we have been inspected by Thai Food and Drug Administration (FDA) for one of our projects and have got several audits by independent auditor assigned from our clients for their projects.
Public health informatics has been defined as the systematic application of information, computer science, and technology to integrate into public health practice, research, and learning. Public health informatics is one of the subdomains of health informatics.
• Public health system analysis and design from ground level to the national large scale
• Mobile health applications
• Data Visualization Training
• National Malaria Surveillance System ( http://malaria.ddc.moph.go.th)
• National Tuberculosis Information Program (NTIP) ( http://tbcmthailand.ddc.moph.go.th/uiform/login)
• E-smart plus by Department of Livestock ( http://184.108.40.206/dldpig/mainpage_newversion.php)
Absolutely, DFdiscover has been designed with security as a key requirement. All access to DFdiscover is restricted to users with valid credentials. These credentials include a verified username and password that are assigned and controlled by a secure DFdiscover administrative account. Requirements are set for password complexity, validity period and if users can individually reset their accounts. User credentials may optionally require Two-Factor Authentication. This is also controlled by the administrative account. Study / database administrators assign roles to user accounts, allowing access to the minimum amount of data and features for the user to fulfill their study role. All user-initiated changes to study data are centrally and separately logged with a username and timestamp. All communication between any DFdiscover user client application and the DFdiscover server is over a direct, encrypted communication channel. The client can always confirm validity of the server that they are communicating with. Communication uses only the most current TLS protocol versions and industry-standard ciphers.
Your data is managed in the validated DFdiscover software (complied with 21 CRF Part 11) and hosted in the server where securely placed in the data center that ISO/IEC 27001:2013 and CSA STAR certified.
On daily basis, the production DFdiscover server hosted in the 1st data center will be backed up to the 2nd data center where will be used as a disaster recovery site. In addition, the study data and all system libraries configuration on the server will also be replicated to the DFdiscover backup server hosted in the 3rd data center as well. A disaster recovery testing can be performed in the system environment of backup server hosted at the 3rd data center.
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