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| Karmic Lifesciences implements Phase Forward’s ClintrialTM 4.6 – an industry leading Clinical Data Management software to handle Phase I to IV clinical trials |
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Mumbai based CRO, Karmic Lifesciences has implemented ClintrialTM 4.6, an industry leading clinical data
management software to strengthen its data management back-end and ensure efficient delivery to its global
clinical trial customers.
As Karmic Lifesciences grew both in volume and complexity of studies, its home-grown data management solution
fell short of its growing needs. Karmic needed a new data management solution to increase efficiency, enforce
standardization, help manage tight project deadlines, and comply with regulatory and reporting requirements. It
was then that Karmic did an extensive evaluation of industry leading solutions and zeroed in on Phase Forward’s
ClintrialTM CDMS owing to the systems ease of usage, ease of integration, low maintenance and versatility.
The ClintrialTM solution (v4.6) was implemented by the IBM India team with Core and Resolve modules based on an
Oracle 10 g platform. The IBM team provided project planning and management, installation services, as well as
training and post-implementation support. Karmic further performed the entire validation exercise i.e.
Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) as per GCP
requirements in conjunction with the IBM team to comply with regulatory guidelines including 21 CFR Part 11.
Says Ms. Nidhi Saxena, President & CEO, Karmic Lifesciences, “Implementing Clintrial early on turned out to be a
wise decision - it has helped us showcase our Clinical Data Management capability to prospective global clients
while improving our data management delivery and productivity substantially by automating key CDM activities,
helping manage discrepancies better and provide customized reporting to our clients. This, coupled with robust
international regulatory compliance as well as great project management from IBM will not only help us deliver
our current business well but also grow new business at an accelerated pace.”
On completion of the implementation project, Ms. Jayashree Thacker, Associate Partner, Global Business Services,
IBM India/South Asia said “IBM is committed to build capabilities to address some very unique business
challenges faced by Indian enterprises. We are very excited about the implementation at Karmic Lifesciences and
especially the fact that this solution will help them to enhance efficiency, enforce standardization and help
comply to regulatory requirements. The healthcare industry is seeing tremendous growth in India and we believe
that a unique solution like this will help organizations like Karmic Lifesciences improve their operational
efficiencies by strengthening their competitive edge in the market.”
Benefits to Karmic
- Phase Forward’s ClintrialTM benefits Karmic’s CDM process by providing rapid clinical data entry and management, extensive coding and reporting features and full CDISC support.
- The system further ensures easy integration with other softwares including SAS, multiple lab management softwares and medical dictionaries including MedDRA and WHO-DD.
- Clintrial’s easy-to-use interface minimizes the need for Oracle® database expertise on-staff thus lowering Karmic’s CDMS total cost of ownership (TCO).
- ClintrialTM ensures full regulatory and audit compliance for Karmic and its global customers.
- With the new data solution, Karmic can further showcase CDMS readiness to prospective global customers in order to expand to new markets.
For further details, mail us at sales@karmiclifesciences.com
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| Featured Case Study |
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| Karmic currently supports a Top 5 Global Pharmaceutical giant for data management across 15+ studies in multiple therapeutic areas over 14+ geographies across the globe |
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| read more >> |
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| Click here to download the PDF file |
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