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Customer Success

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Customer Success

 

Clinigene uses SAS® to accelerate clinical trials

Clinigene International Limited is a full-service clinical research organization that partners with global pharmaceutical and biotechnology companies in their clinical development programs. Clinigene focuses on quality and adds value to its clients' clinical development programs by evolving various strategies to ensure timely execution of clinical projects and cost-competitive services.

Clinigene works diligently to define the number of desired participants in the trial. This number is arrived at statistically based on various factors that may lead to screen failures or possible elimination due to adverse events. Clinigene has established an efficient process for identification and recruitment of trial participants. 

The challenge
One of the critical success criteria in clinical trials is patient recruitment and retention. Without sufficient patient retention from start to finish, the number of remaining participants may prove to be too small a pool from which to derive conclusive results for the trial's sponsor.

The adverse events observed are captured at the respective trial site. The CRF is transferred to the data management team for analysis and reporting. That could take an average of 15 days, because the clinical data is captured in a clinical data management (CDM) system, collated, and then exported to an analytical solution, like SAS Analytics, to derive required reports.  All the while, the participant exhibiting the withdrawal criteria continues in the trial and adds additional costs to the sponsor during this period. Changes in lab parameters from the baseline may also qualify the subject to meet the withdrawal criteria.

A greater challenge is when such patient disqualifications lead to a possible reduction in the pool size of participants.

Why SAS®?
Mr. Manoj Yasodharan is in charge of data management and biostatistics for all clinical trials conducted at Clinigene. His team is responsible for collating the data from the sites and generating statistical reports on the study's progress as well as for its final results.

Manoj says, “SAS provides a complete solution for clinical data management and analysis. We have successfully reduced the time for setup for new trial projects. SAS partnership has helped us in setting up our own server thereby giving us complete control over the entire data management, analysis and reporting process.” Clinigene partnered with SAS for a solution. With SAS, Clinigene was able to accelerate clinical research for both paper as well as electronic data capture trials. SAS provides a state-of-the-art CDM solution with its own database.

Further, SAS powers the statistical analysis and report generation from the same database. "This prevents the need for maintaining two systems – one for CDM and another for analysis. SAS enables us to statistically analyze and report on the trial project quickly," says Manoj.

SAS provides an efficient, cost-effective, easy-to-use EDC solution with data-management features, including a unique portal that integrates data entry with data transformation, data imports and exports, and data analysis and reporting.

SAS is the de facto industry standard for statistical analysis and clinical-trials reporting.

SAS incorporates the technical controls for 21 CFR Part 11 compliance, thereby helping Clinigene meet regulatory and audit requirements. Along with EDC capability, SAS enables Clinigene to deploy a hybrid system consisting of both electronic and paper-based records.

Complete control
Clinigene is the first Indian CRO to execute EDC trials successfully from an in-house infrastructure.

That capability gives Clinigene complete control over data management and analysis. Clinigene is able to record and generate reports whenever needed without any further process bottlenecks or lead time. With help from SAS, Clinigene has reduced the amount of time between data capture and report generation – from 15 days to just two or three days. Thus, any disqualification of a patient can be identified within a couple of days.

Key benefits
With profile-based access, SAS enables Clinigene to grant access permissions to a variety of users such as principal investigators, database managers, project managers, CRAs and others.

SAS comes with its own data storage, thereby eliminating the need for a separate database.

The SAS solution can be deployed within a week and its CRF creation exercise can be completed within a short time. Thus, Clinigene is able to speed the setup of new projects for their sponsors.

With SAS, Clinigene provides a complete CRO solution because its clinical data management services are compliant with global, uniform standards of conduct and standard operating procedures that meet FDA and ICH requirements.

Copyright © SAS Institute Inc. All Rights Reserved.

Mr. Manoj Yasodharan
Head of Data Management & Biostatistics
Clinigene International Ltd.

Clinigene

Business Issue:
Integrate data sources into a central repository for quick analysis of real-time data and online validation of patient eligibility
Solution:
SAS for clinical data management 
Benefits:
Web-based solution reduces the time between data capture and report generation from 15 days to about two or three days

SAS provides a complete solution for clinical data management and analysis. We have successfully reduced the time for setup for new trial projects. SAS partnership has helped us in setting up our own server thereby giving us complete control over the entire data management, analysis and reporting process.

Mr. Manoj Yasodharan

Head of Data Management & Biostatistics

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