The Department of Biostatistics has advanced systems to manage the delivery of large volume of data and clinical data with its leading-edge technologies. We have designed our IT systems and associated SOPs to comply with FDA (Food and Drug Administration) “Guidance for Industry – Computerized Systems Used in Clinical Trials” and FDA 21 CFR Part 11 regulations.
The IT infrastructure is designed to be secured to support our data management and Biostatistics services; with a focus on large-scale data management and electronic data capture (EDC) solutions.
To ensure the highest level of security and to maintain the functionality of EDC, we have designed a multi-layered network with multiple firewalls to mirror these activities. This architecture also ensures that only fully authenticated users are able to access our internal LAN. Our security protocols begin with controlled access to the premises, workstations and servers; followed by controlled access to the databases and systems over the Internet, intrusion detection, virus scanning at all ports of entry.
We have developed a comprehensive set of SOPs to address all the key aspects of our IT department/network maintenance from backup policy, disaster recovery plans, and procurement rules for hardware and 3rd-party software applications, to system and software validation and change control. A separate set of SOPs govern the development and maintenance of our internal applications.
As mandatory procedure by our SOPs, our systems and their associated SOPs undergo periodic independent Audit.
The department of Biostatistics is the paramount in clinical data management services. It is a large-scale data management office where the prime approach is to provide the clients with clinical data management solutions that are customizable to client requirements, cost-effective, secure, regulatory-compliant, accelerated data collection process, regardless of the data collection method the clients choose.
Supported by our leading-edge data management systems and integrated SOPs, our staff can fulfill unique project requirements, such as:
Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines.
The following is a summary of our data management services and procedures:
To ensure the integrity and accuracy of the study data our Project and Data Managers follow QC and QA processes. Our QC process involves periodic review of:
Our secured and FDA21 CFR Part 11 compliant EDC system with its intuitive user interface is used to host your studies on-line.
The key benefits include rapid deployment, comprehensive online data validation, rapid change management, and experienced user support. Our system and services ensure analysis-ready data at any time.
Our experienced group of Project Managers (Coordinator), Database Managers, Database Coordinators, Data Reviewers and System Administrators direct and maintain the entire EDC process for our clients. Their responsibilities include:
All project related personnel (Investigators, Coordinators, Monitors, Data Reviewers, and Sponsors etc.) can easily navigate through all study data (CRFs and DCFs) and status reports with a standardized user-friendly interface.
Oracle provides integrated; complete solution for design, conduct and managing of Paper, EDC and hybrid clinical studies. The solution consists of
Key benefits of using Oracle clinical are as follows
Promasys is an integrated clinical data management and EDC system that brings quality and efficiency to your clinical data capture and data management processes. On top of industry standard data management functionality -which is available to the users without having to do any programming- Promasys offers rich reporting and work flow support solutions, like automatic distribution of subject recruitment progress reports, automatic generation of bar-coded sample tube labels, work lists, data listings and SAS data sets, etc.
Some of Promasys' main features include:
EDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data (including 21 CFR Part 11, FISMA, and HIPAA-compliant environments), it is specifically geared to support online or offline data capture for research studies and operations. The REDCap Consortium, a vast support network of collaborators, is composed of thousands of active institutional partners in over one hundred countries who utilize and support REDCap in various ways.For more details please visit here
OpenClinica is a web-based clinical data management software platform for managing clinical research studies. Protocol can be configured and data could be collected using either paper CRFs or Electronic CRFs.
Some of the key features of OpenClinica: