Our data management team is using the most advanced and comprehensive data management software available and according to the highest regulatory standards to ensure auditable Good Laboratory Practices(GLP) quality results and with the required levels of efficiency to keep your drug development and medical device programs on track.

The data management team through its unique software especially designed to provide a high level of flexible & specialized data management services is able to track & report data in a format helpful in managing your specified protocol.

Our web based report viewer is a highly secure web-based tool enabling real time review of lab reports, which can be printed or saved for future reference.

Our data management team interacts closely with our investigators. Our data management service division.

• Determines the preferred format and frequency of data transfer.
• Helps ensure customized data file.
• Monitors pre-determined intervals of data transfer.
• EnsuresWeb-based e- trials.
• Provides Data handling Manual.
• Provides Blind and independent double data entry.
• Provides on demand comprehensive data validation reports.
• Ensures full electronic Audit Trail.
• Provides Computer–generated and fully tracked Data Clarification Forms (queries).
• Conducts regular audits.

Audit Process
We take the following points in consideration:

• Verify that the protocol is performed according to good lab practices (GLP) and International Commission on Haematology (ICH) standards and the Standard Operating procedures (SOP’s).
• Review the content and process.
• Inspect study required facilities and equipments.
• Verify that the data collected in a representative sample of Case Report Forms (CRF-s) are supported by source documents.
• Assess compliance with internal SOP’s.
• Study documentation audit.
• Verify that the protocol is performed according to GLP and ICH standards.
• Review records and procedures for site visits.
• Review study file documentation
• Ensure internal system used in the conduct of clinical trials are correct, including SOPs for Adverse Experience (AE) reporting, supplies distribution, and data handling.
• Assess compliance with internal SOPs.
• Compare study report versus the protocol, CRF- and database.
• Ensure internal consistency in report.
• Preparation for regulatory inspection.

Investigation Audit covers

• Trial master file audits.
• System audits.
• Site audits.
• Central laboratory audits.
• Data base audits.
• Final clinical report audits.

Web based reporting

Our web based report viewer is a highly secure web-based tool enabling real time review of lab reports, which can be printed or saved for future reference.laboratory reports get uploated on to our web site on a real time basis ,thus reducing the time of report delivery by other means.

Features:

• Certified web site.
• Unique username & password generation to view study specific reports.
• Real times upload of reports.
• Easy to use tool.
• View, save & print options for easy access of reports.

Electronic Data Transfer

Based on your specific requirements Electronic Data Transfers can be customized to meet your requirements.

We offer a range of delivery mechanisms for the Electronic Data Transfers such as

• Password protected zip file through Email
• CD via courier
• Direct upload into your system

Customization of hard copy reporting
Our flexible and specialized approach enables us to report out laboratory results with various levels of customization to meet the protocol design such as:

• Laboratory result reporting in conventional units
• Delta checks
• Exclusion and alert value notification as comments