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IT Services

IT Infrastructure

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.

Data Management

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.

  • Paper to Electronic Data Capture
    • Remote Data Entry (Client – Server)
    • Web based

Supported by our leading-edge data management systems and integrated SOPs, our staff can fulfill unique project requirements, such as:

  • Quick database set-up
  • Sponsor-defined CRF and DCF management rules
  • Accelerated query management
  • Study timeline changes
  • Changes to Protocol, CRF Template and project specifications

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:

  • Data Management Plan
    • Project-specific data management standards and SOPs
  • Database Design
    • Database definition
    • Database security
    • Data entry screens
  • Data Validation Plan
    • Initial programming
    • Validation Check Specifications documents
    • Testing and locking data validation plan
    • Periodic re-testing
  • Data Entry
    • Ongoing data entry from CRFs – single or double entry
    • Data entry cleaning
  • Medical/Science Review
    • Review of marginal notes on CRFs and Data Alerts
    • Evaluating medical and scientific consistency of data
  • Medical Coding
    • Coding of adverse events (MedDRA ,WHOART or WHODrug Dictionary)
    • Coding of concomitant drugs (WHODRUG)
  • Data Validation and Query Management
    • Periodic validation of CRF data
    • Flexible query routing
    • Accommodating 3rd party queries (SAS, SPSS, STATA,SUDAAN)
    • Query and resolution management
  • Central Lab Database Imports
    • Incorporating 3rd party databases
  • Database Lock and Audit
    • Interim and final database locks with associated documentation
  • Database Documentation & Release
    • Database transfer in Sponsor defined formats (ASCII,SAS,XML etc.) with detailed documentation

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:

  • CRF and DCF tracking and filing
  • Data entry errors and data management procedures
  • Data entry vs. Original paper CRFs

Electronic Data Capture (EDC)

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:

  • Study set up
    • Specify project parameters and project team
    • Issue user certificates
    • Define access privileges
  • Design user-friendly data entry screens
  • Implement on-line data validation
  • Produce/customize status reports and data listings
  • Trial protocol and on-line help
  • Database exports and locks
  • User support

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.

CDM Tools

Oracle Clinical

Oracle provides integrated; complete solution for design, conduct and managing of Paper, EDC and hybrid clinical studies. The solution consists of

  • Oracle Clinical, a Clinical Data Management System for conducting and managaing paper and electronic studies,
  • Remote Data Capture for conducting and managing Electronic Data Capture (EDC) trials,
  • Thesaurus Management System for mnaging dictionaries required for medical coding during clinical trials

Key benefits of using Oracle clinical are as follows

  • Single study definition tool for paper and electronic data collection and support for hybrid studies
  • OC provides a Global Library Management that enables enforcement of global data standards like SDTM; Using global library facilitates rapid study set-up by re-using standard objects.
  • Proven compliance platform for various regulatory requirements including FDA’s 21 CFR part 11, GCP guidelines etc.
  • Ease integration with external systems (workflow, imaging, OCR/ICR, Barcode Systems, additional data collection devices)
  • Interface for defining complex validation checks, including configurable online checks, without the need for PL/SQL skills
  • Handling Unplanned Pages / Visits
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Promasys 7.0

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:

  • Easy setup of new trials; use templates and recyclable trial design elements
  • Paper CRFs, EDC screens, iPad app screens, forms and labels are all generated from the clinical database design
  • Build edit checks without programming
  • Manual queries and system generated batch queries
  • Full audit trail compliant with 21 CFR part 11
  • Electronic signatures
  • Set & forget access control, dynamic access rights management through the Study Life Cycle
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RedCap

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.

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OpenClinica

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:

  • ICH-GCP, 21 CFR part 11 and HIPAA complaint
  • Manages multiple studies using single interface
  • Design eCRFs
  • CRF version support
  • Design rules/edit checks
  • Schedule subject visits
  • Re usable study components
  • Role based access control
  • Extensive interfaces for data entry (single / double)
  • Built-in Query Management support
  • Extract data in various formats for analysis and reporting
  • Audit trial and electronic signature
For more details please visit here