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Contract Research Organization (CRO) Services

Pharmaceutical, biotechnology, and medical device companies are grappling with multiple challenges today: escalating costs of conducting clinical trials, increasing regulatory complexities, the need to maintain data quality, enrollment targets, the financial demands of setting up a clinical research practice, the management of multiple stakeholders, and much more. Finding a reliable technology partner to aid in software development and help overcome these challenges is of prime importance for medical devices and pharmaceutical companies.

HCL’s full-service CRO team provides complete software-led solutions for global pharmaceutical, biotechnology, and medical device companies involved in clinical research. The team comprises a complementary group of professionals in medicine, nursing, pharmacology, microbiology, toxicology, statistics, and law. Collectively they contribute a wealth of experience in the drug discovery and clinical development arena, gained in the U.S., U.K., and India. Through this expertise, as well as relationships with investigators in India, robust technology, flexibility, and strict adherence to guidelines and regulations, HCL provides customers with high-quality and cost-effective services.

Services Offered

An array of end-to-end clinical research services (Phase I to Phase IV) in multiple therapeutic areas:

  • Study design
  • Investigator meeting support
  • Protocol development
  • Data management
  • Regulatory consulting
  • Biostatistics
  • Regulatory liaison
  • Medical writing and clinical study reports
  • Project management
  • Study drug storage and logistics
  • Site management
  • Central lab coordination
  • Site monitoring
  • Study drug import management
  • Adverse event management
  • Study feasibility support
  • GCP audits
  • Pharmacovigilance services


Capabilities for filing clinical trial applications and supporting applications like Import and Export License in India:

  • Submission dossier preparation
  • Submission dossier quality check for completeness and compliance
  • Submission and Tracking
  • Filing of all submissions
  • Submission tracking
  • Submission query resolution

Medical Writing

  • Clinical study reports
  • Clinical sections of CTD/NDA
  • Investigator’s brochure
  • Manuscripts
  • Clinical trial protocols
  • Abstracts
  • Informed cnsent forms
  • Posters
  • Risk profiles
  • Slide kits
  • Patient narratives
  • Literature searches

Safety Surveillance

  • Review of protocol , investigator brochure, informed consent form, and case report form
  • Organize independent data monitoring board
  • Safety monitoring
  • Periodic safety update reports (PSURs)
  • SAE collection, evaluation, classification, and reporting to central IRBs/sponsors /regulatory authorities
  • Drug safety update reports (DSURs)
  • Safety database development
  • Periodic adverse drug experience reports (PADERs)

Clinical Data Management

  • Database and eCRF design
  • Data processing and migration
  • CRF management
  • Data generation for analysis
  • Double data entry
  • Trial scalability and site flexibility
  • Electronic data capture
  • Transparent/seamless data conversion
  • Data validation and review
  • Quick setup time and economical cost
  • Medical coding using MedDRA  and WHO Drug


  • Protocol development, including sample size and power calculations
  • Interim analysis for early decision making
  • Randomization schedules
  • Tables, listings, and figures validation and quality control
  • Statistical analysis plans
  • Integrated summary of safety (ISS) and efficacy(ISE) summaries
  • Analysis dataset programming and documentation
  • Ad hoc statistical support
  • Clinical and statistical SAS® programming (generation of tables, listings, and figures programming)
  • Interpretation and reporting of data for clinical trial reports and publications
  • CDISC® study data tabulation model (SDTM) mapping and conversion, generation of ADaM (analysis of data models). HCL has pioneered CDISC metadata BRIDG conversions.

Quality Assurance

  • GCP, GLP, and GMP audits
  • SOP management
  • Investigator site audits
  • Quality systems training and development
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We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.