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Life Sciences

 

Challenges We Address

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The Life Sciences industry is facing constant challenges particularly over the last decade, as a result of the overall economic downturn and the expiry of block buster product patents, causing a steep decline in revenues and the pressure to do more with less. Stringent quality measures are also compelling pharmaceutical companies to start adopting newer and more relevant technologies to stay ahead. The major areas of concern include:

  • A steep decline in R&D productivity
  • An increase in R&D expenditure
  • A decrease in the number of new drugs being approved
  • Increased pressure to become more cost efficient
  • Changing regulatory standards

As a remedy to these concerns, HCL offers optimized Life Sciences outsourcing solutions that drive operational efficiency, optimize R&D expenditure, and provide high quality professional services together with the required compliance.

HCL’s BPO Services for the Life Sciences Industry

Serving clients under a single umbrella of enterprise functions, HCL offers all the clinical requirements of global sponsors, through a customized solutions approach. HCL’s end-to-end clinical research and post marketing support services include:

Clinical

  • End-to-end CRO services
  • Clinical Trial Transformation- Remote Central and Risk Based Monitoring
  • Clinical Data Management and Biostatistics
  • Medical Writing
  • Patient Support Programs for more accurate and on time Clinical Trial Data
  • EMR Analytics based Site Selection and expedited Patient Recruitment services

Pharmacovigilance

  • Adverse Events Case Processing with HCL’s end-to-end utility service model
  • Aggregate Reporting and Periodic Safety Update Reporting (PSURs)
  • Signal Detection and Risk Management (REMS) programs
  • Individual Case Safety Reports (ICSR) Services
  • Clinical Evidence Summary Writing

Regulatory

  • Regulatory Information Management
  • Regulatory Submissions
    • eCTD
    • NeeS
    • Paper format
  • Electronic Trial Master File (eTMF) Processing Support
  • Quality Assurance Process Management
  • Global Market Access Consultation
  • Identification of Medical Product (IDMP) support

Sales and Marketing

  • Disease Management -  Patient Support Programs, medical counselling by Health Care Professionals (HCP) for better compliance, adherence, life style improvements and program outcome analysis
  • Remote Telemedicine by Health Care Professionals
  • eLearning solutions for sales representatives
  • Socialytics – Listening post for the patient’s independent sentiments about various drugs
  • Contact Centers for supporting product launches, market access, clinical trials support, and sales force authorization support for sales representatives.
  • Virtual Marketing Representatives - Telemarketing to prescribers using the latest technology

The HCL Advantage

Innovative solutions :

  • rHorizon: HCL’s transformative solution for Remote Central and Risk Based Monitoring. A solution driven by highly configurable rules based analytics and other data driven initiatives focused on clinical development, provides huge savings to the Pharmaceutical industry.
  • Patient Support Program for Clinical Trials: With a goal to increase patient awareness and compliance in clinical trials, and for timely patient adherence and visits ensuring a higher quality of trial data, HCL has designed the solution including a web portal and mobility application support, to cater to global Pharmaceutical clients.
  • Global Electronic Submission Support: Regulatory submission, and publishing and maintaining marketing authorization are supported electronically with the help of tools and platforms recognized by the industry and the market, globally. HCL is equipped with trained and certified resources to excel in regulatory horizons.
  • On Cloud Trial Master File Management: HCL manages Clinical Trial Master Files adhering to US FDA 21 CFR Part 11. Our on-cloud eTMF platform supports a metadata vocabulary classification system for better search ability, electronic interoperability, and electronic signatures.
  • Device Specification (P2 Remediation and CER/CES Writing) Support: HCL offers solutions within Medical Writing and Medical Device risk evaluation areas to support Medical Device organizations. These include: monitoring risks reported in worldwide literature related to the use of medical devices (P2 Remediation), calculating the overall risks associated with devices to plan risk mitigation strategies, reviewing published literature, clinical studies and device registries for continued safety and efficacy of marketed Medical Devices, and  developing, reviewing and revising Clinical Evaluation Summaries (CES) for Medical Device organizations.

These solutions leverage HCL’s extensive experience of over 12 years and over 75 Clinical Trials to provide end-to-end clinical research services in multiple therapeutic areas.

A broad footprint:

  • From Drug Discovery to Post Marketing Services: HCL’s experts offer services in the critical areas of drug discovery and development, clinical development, regulatory submissions and compliance, drug safety, pharmacovigilance, data analytics, and patient support programs for clinical trials and after approval marketing for better adherence and compliance.
  • From Regulation Adherence to Expertise:  HCL’s customers also benefit from its Life Sciences Competency Center (headed by industry experts, including HIPAA, PMP, and GCP certified professionals), and delivery teams supported by doctors, PharmDs, PhDs and scientific researchers.
  • Integrated Global Delivery Model (IGDM): HCL leverages its IGDM  with 31 delivery centers across the globe, and  serves global industries including Pharmaceutical, Bio-Pharmaceutical and Medical Device organizations.

Flexibility :

HCL believes in flexible business models such as the Functional Service Provider model, to provide solutions specifically for globally spread businesses. These innovative and customized engagement models through our "skin-in-the-game" approach with flexible commercial constructs helps clients create a significant business impact.

Business Value to Customers :

  • HCL’s CRO services can provide Clinical Trial Transformation - Remote Central and Risk Based Monitoring solutions, to deliver cost savings of up-to USD 3 Million per year, for monitoring activities.
  • The average length of therapy in Patient Support and Disease Management programs has been increased by 6 to 8 months, thus bringing a positive impact on pharmaceutical companies’ top line revenues and improvement in the quality of life for patients. This successful program is also positioned for Clinical Trial Patient Support for more accurate and timely data, and protocol compliance while working with investigators.
  • Delivering clinical excellence with a global sourcing model has been HCL’s unique proposition. The CRO business unit at HCL drives clients’ businesses beyond a cost savings framework. HCL’s CRO improves operational flexibility and reduces cost by over 35% in Clinical Trial Monitoring and Regulatory Services.
  • Sponsors benefit by meeting or exceeding trial timelines with improved site performance and EMR analytics-based site selection and expedited subject recruitment strategies.
  • Providing Trial Design solutions by extracting metadata from a protocol to create CDISC and non-CDISC (sponsor specified) datasets.

Comprehensive industry experience :

Seven of the top ten global pharmaceutical companies have trusted HCL for nearly a decade to help develop affordable, value-based business methodologies.

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Regulatory Submission Services
Regulatory Submission Services
Clinical Trial Transformation
Clinical Trial Transformation
Patient Support Program
Patient Support Program
Life-Sciences Offering
Life-Sciences Offering
Medical Writing
Medical Writing
Clinical Data Management
Clinical Data Management
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