Drug Development

Industry Challenges

One of the major challenges besetting the Pharmaceutical industry today is declining R&D productivity. R&D productivity is considered a function of pipeline output vis-à-vis three factors - investment, rate of innovation and time-to-market. Traditionally, pharmaceutical companies have been investing heavily in R&D to boost productivity. However, the greater scale in R&D is no longer translating into proportional improvement in the pipeline value. Pharmaceuticals companies therefore have to find new ways to push up the productivity.

Boosting efficiencies in the clinical trial process is fast emerging as a sure route to increase productivity. Given the fact that approximately 45% of the overall R&D budget and at least half of the time to market are consumed by clinical trials, improving efficiencies in the clinical trial process will naturally accelerate product development.

While, the Pharmaceutical industry has been relatively slow to exploit the advantages of web technology, its wider use is a certainty and will be substantially accelerated by the global harmonization of data/systems standards and consequent shift to integrated clinical data management. Some of the main challenges in drug development are:

• Increased development time and costs due to increase in drug development requirements
  • Increasing number of procedures and criteria
  • Number and size of trials
  • Regulatory requirements
• Cost Effectiveness and Time to Market emerge as key imperatives

HCL Differentiators

• Corporate Patron of CDISC – working on next generation CDM models
• HCL's Validated Quality Management System has been audited by at least 3 of the Big Pharmaceutical companies in the past one last year alone.
• Knowledge of Phase Forward Clintrace, Oracle AERS, Relsys Argus Safety and Aris Global ARISg and coding systems like MedDRA and WHO Drug Dictionary
• The team possesses in-depth technological and practice-related expertise. It is staffed by technology experts in Net/J2EE/Testing/etc domain experts in EDC, CTMS, CDMS regulatory affairs consultants (RAC) and CDS/COTS application experts (Phase Forward, Oracle, Medidata, Siebel) etc.
• The team also derives strength from HCL's extensive experience in the Life Sciences space. HCL's experience spans Pharmaceutical, CROs and Product companies working in clinical research space. We works with 9 of the 15 top global pharmaceutical majors. The team also draw upon HCL's 750+ Life Sciences (non-healthcare) team that is well versed with:
  • US FDA, Europe EMEA, India DCGI
  • LCH/GCP/GCDMP/CDISC/21CFR Part 11
  • SOPs
  • MedDRA
  • WHO Drug Dictionary

Service Offerings

HCL's Drug Development CoE empowers pharmaceutical companies to boost efficiencies in the clinical trial process by providing them:

CTMS

HCL's Streamlined CTM & Data Migration services enable a smoother clinical trial experience. HCL's CTMS service line include –

HCL's CTMS professionals have proven skills in:

• Project management
• Data modeling, Software development
• Data analysis
• Data mapping and Problem Resolution
• Computer system validation
• Regulatory compliance

Oracle Clinical - HCL, in partnership with Oracle India, provides installation, validation, and training for Oracle clinical software. HCL provides a comprehensive suite of Oracle Clinical support and implementation services, from initial implementation and validation assistance to and beginner-level training through process definition and more advanced trouble-shooting tips. HCL also provides assistance in the re-designing of data management processes to fit Oracle Clinical functionality, along with the creation and maintenance of standard operating procedures, guidelines and work instructions.

Phase Forward – HCL's Phase Forward Implementation services aim at shortening the time from licensing to launch. HCL's global services team, with the combination of application technology and industry expertise, not only efficiently implements Phase Forward applications to lower your total cost of ownership, but also integrates them with other applications in your clinical systems portfolio, whether developed in-house, by a third party, or by any of Phase Forward's partners.

Legacy Data Migration

HCL's legacy clinical data methodology is as follows:

1. Evaluation of data resources
2. Detailed requirements defined for conversion paying special attention to complexities in both SOURCE and TARGET systems especially relating to system customizations as well as addressing AUDIT table migration strategies
3. Project plan with a milestone timeline
4. Mappings from current to future database models are designed, documented and reviewed client
5. Conversion software is developed, tested and validated to 21 CFR Part 11 requirements
6. Assistance with configuration or customization of the new TARGET system, if required
7. Dedicated onsite and offshore support

CDMS

Under CDMS, HCL provides a whole gamut of services starting from protocol development to final submission and reporting. Briefly the entire value chain of services can be roughly described as:

HCL's offers Optimized CDM solutions for transformational benefits. HCL's optimized CDM is based on a 5 step virtuous cycle:

1. Shifting the CDM paradigm
2. Reengineering the existing CDM processes
3. Measuring Process Effectiveness
4. Enabling process maturity
5. Leveraging management excellence

HCL provides end-to-end solutions to optimize the CDM process by fitting in as a Functional Outsourcing Specialist, with integrated offerings (Applications+BPO+Infrastructure). This comes from an understanding of overall business and adherence to industry forums like CDISC, ACDM, SCDM, etc. Moreover global partnerships with Tokushima University & Supercomputing Center for Bioinformatics & Computational Biology, IIT Delhi raise the standards of services HCL provides to its clients.

AERS/Drug Safety Solutions

HCL offers advanced Drug Safety Offerings for a smoother AERS experience:

• Selection, Implementation and Configuration
• Drug Safety Software Support Services
• Drug Safety Software Integration Services
• Consulting & Validation Services

Meeting pharmacovigilance requirements needs trained individuals to code and clinically assess cases. HCL's safety teams are kept abreast of regulatory requirements at regional, national and international levels. They have expertise in addressing workload that will have peaks and troughs, particularly marketed products that are taken seasonally allowing Pharmaceutical companies to focus on their core competency of drug discovery.

Medical Coding

The main medical coding challenges faced by pharmaceutical industries include :

• Lack of consistency of adverse reaction, disorder and drug coding across business functions
• Huge data reconciliation tasks, and Sub-optimum pharmacovigilance performance

HCL's medical coding offerings include:

1. Dictionary definition and loading into MedDRA, Oracle TMS, Clintrace, Clintrial, and other systems
2. Automated support for version upgrades and impact analysis
3. Auto-coding algorithm implementation
4. Assistance with medical coding and manual reclassification
5. Acceleration of re-coding of legacy terms

The best practices leveraged by Drug Development team include:

• SLA based Delivery Management
• Real Time Access to Web Based Project Portal/Dash-Board
• Metrics (Schedule, Defect, Traceability etc.)
• Continuous skill enhancement through formal/on-the-job training
• Formal periodic reviews
• Proactive Investment in building Domain expertise
• Weekly/Monthly Status Reports
• Resource Forecasting
• Rebadging Contract resources