| Life
Sciences Case Study
Client
A leading contract research organization conducting
clinical trials
Customer need |
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To streamline operations in the Clinical
Research Labs offering clinical services covering
Phase I, II & III testing |
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Pathology, diagnostic and analytical services |
Challenges |
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An enterprise-wide Clinical Trials Data
Management System (CTLIMS) to functionally
manage the clinical trial life cycle and integrate
pathological and analytical data |
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Eliminating paper forms, the study results
would be available after completion |
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Compliance with US-FDA guidance and approval
process, through online data submission
|
MphasiS Solution
Detailed analysis revealed that none of the available
off-the-shelf products could meet client expectations
or business needs. MphasiS’ team of domain
experts in the clinical and Pharma streams, along
with system architects proposed devising a custom
application to run operations.
The MphasiS team was involved in the requirement
analysis and design of the Clinical Trial Management
System specifications to capture, validate, manage
and report data from clinical & analytical labs.
A web-based solution using Java TOMCAT, Apache,
using Oracle 9i database, and Crystal Reports in
compliance with regulatory compliances such as 21CFR11
GCP and GAMP was proposed.
Features included:
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Volunteer Registration & Screening
(using Biometric/ Web Cam interface) |
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Study Design (includes Study Protocol,
IEC/IRB approvals, Drug Randomization) |
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Consent registration |
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All aspects of Path Lab management |
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Online Pathological analysis request and result
viewing |
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Pathological sample tracking and online data
management |
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Clinical & Analytical Lab
Management (Sample Bar coding interface, Sample
Tracking, Workflow Management, HPLC/MS/LC Interface,
SAS interface, Document Control, Reporting) |
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Inventory / Resource Planning & Management |
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Configurable & Automatic report generation
suited for FDA submissions |
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Online QC & QA verification & validation
process, audit trail and versioning etc |
The CTLIMS solutions have to be stringently tested
and developed using a process which has FDA compliance
from day 1.
Business Benefits
|
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A complete and customized, online
Clinical, Pathological and Analytical data capture
and management solution to suite the business
and operational need of the customer |
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Well-defined online Work flow
with QC & QA process |
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Regulatory compliant application |
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Configurable & dynamic reports |
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Flexible design to fulfill future
CRO requirements |
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Within Budget and on time
delivery
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