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Clinical Transformation

 

The Situation Today

As patents on blockbuster drugs expire, regulatory scrutiny increases, and the global market becomes ever more interconnected, companies in the life sciences industry are attending to challenges and opportunities on many fronts. One of the most exciting is the transition to personalized medicine, a paradigm shift made possible by translational research and technological innovation. Next-generation research and development (RD) is patient-centric, thus demanding RD platforms that are agile and disruptive, fostering innovation and collaboration while supporting the emergence of SMAC (social media, mobile technology, analytics, and cloud computing).

How HCL Can Help

As the largest IT application development and maintenance provider for pharmaceutical RD, we draw on extensive experience and expertise in strategy, implementation, and product support across the industry’s Research and Development value chain — from lab information management systems (LIMS) to clinical development, pharmacovigilance, and regulatory submissions. HCL is currently involved in one of the largest implementations of an integrated RD platform, supporting over 390 applications across the RD value chain.

Clinical Transformation

Our unique clinical transformation services and solutions take a 360-degree view of the RD transformation process:

  • Data Interchange as a Service Platform (DiaaS):
    HCL’s platform facilitates the onboarding of contract research organizations (CROs) and the exchange of operational and patient data between sponsors and CROs according to sponsors’ standards.

  • Unified Clinical Platform (UCP): 
    Our scalable and secure RD lab on the HCL cloud enables the accelerated implementation of Oracle Health Sciences products to support next-generation RD platforms and provides comprehensive data modeling (BRIDG-based) and proprietary tools and accelerators for functionality enhancements and improved user experience.

  • Risk-Based Monitoring Solution — rHorizon: 
    Customers can optimize site monitoring through HCL’s rHorizon platform-led knowledge process outsourcing (KPO) , drawing on more than ten years of experience in trial monitoring, technology transformation, and back-office processes.

  • Drug Safety Utility Platform (DSUP):
    Our cloud-based solution, which leverages HCL’s regulatory compliance services, promotes operational excellence, externalized clinical adverse event (AE) case intake and processing as well as safety and spontaneous AE reporting.

  • CDISC Conversion Platform — Panther:
    HCL’s metadata-driven, cloud-based platform for the conversion of clinical trial data to any company specified format (SDTM, ADaM, BRIDG) is cost-efficient and utilizes a factory-based approach.

What You Can Expect

  • Faster time to market with higher quality and greater productivity
  • Next-generation RD platforms that enable externalization and partner collaboration
  • Relief from managing operational complications and data eccentricity associated with CRO data exchange
  • Increases of nearly 50% in customer satisfaction
  • Overall cycle time reduction and savings of up to 50% across RD functions in maintenance and support, implementation, and business processes

Our unique clinical transformation solutions provide additional specific benefits:

  • DiaaS
    • Ability to support multiple environments with no upfront capital investment by sponsors
    • Reduced operational complications and data eccentricity associated with CRO data exchange
    • Cycle time reductions of up to 40%
  • UCP
    • Improved ability to handle disparate data sources
    • Reductions in configuration time of up to 80% as a result of better acceptance by statistical analysis system (SAS) programmers and clinical staff working with life sciences hubs (enhancements in LSH with data-driven event monitoring and improved fraud detection signals)
  • rHorizon
    • Potential reductions in clinical trial timelines through improved quality and integrity of data
    • Reductions of up to 40% in the costs associated with clinical site monitoring
  • DSUP
    • Virtually unlimited scalability and complete security
    • Improved and cost-effective safety processes
    • Ability to support multiple commercial off-the-shelf (COTS) and business process management (BPM) systems
    • Savings of up to 30% in the intake, processing, and reporting of adverse events
  • Panther
    • Virtually unlimited scalability and complete security
    • Reductions in sponsors’ time and resource requirements
    • Simplified pricing, with an average of USD 10,000 per study

For more information, write to us at: contact.lsh@hcl.com

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What Customers Say

“In my career of 17 years working at Merck I have worked with several different contractors and consulting agencies. The thing that I find really unique with HCL compared to any of the other relationships is their focus on partnerships.”

— Director, Global Security, a top-three global pharmaceutical company