Biopharma: The Future of Health
New drugs. New pressures. New paradigms.
The pressures on biopharmaceutical companies to deliver on clinical outcomes while managing costs and regulations have never been greater.
How do you balance R&D investments while operating at lower margins?
How do you achieve transformational health outcomes against the backdrop of regulatory scrutiny and regulation?
Accelerate your organization's digital transformation journey and unlock greater value and ROI in today's rapidly evolving landscape with solutions from HCLTech.
Solutions for the Biopharmaceutical Industry
With a focus on patient-centered pharma R&D, HCLTech empowers enterprises with biopharma-specific solutions that unlock the power of innovation.
Confidently evolve with changing regulatory standards
When agencies such as the European Medicines Agency (EMA) and American Medical Association (AMA) provide a phased plan for defining and implementing standards, life sciences CIOs and business leaders need a flexible system that can evolve to meet the standards as they get released.
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Confidently evolve with changing regulatory standards
Our IDMP-360 platform provides a flexible and configurable platform approach to meet the evolving IDMP standards, developed on the industry-leading Appian platform.
Key features of our IDMP-360 Platform include:
- Fully compliant cloud-based custom configurability
- Enable data, processes, people and change management for IDMP
- Flexibility for management of evolving IDMP standards through robust Master Data Management
- Versatile data integration, aggregation and data curation
- Get 360-degree visibility of data and records
- Provide meaningful insights for decision makers
- Complete data lineage to address compliance and traceability
- Lower compliance management efforts
- Role-based user experience
- Extend the benefits to other stakeholders from research to supply chain, through extensible UI
Improve pharmacovigilance with AI
Pharmacovigilance has been a labor-intensive case processing-based industry.
Radically alter the pharmacovigilance landscape, leading to better identification, reporting and resolution of adverse events leading to lower costs for pharma companies and healthier patients.
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Improve pharmacovigilance with AI
An average drug costs over $1B to bring to fruition from discovery through development and launch phases. These expensive "blockbusters" face even riskier futures in the event of regulatory drug withdrawal decisions/recalls.
Optimize clinical data collection and reporting
Optimize data collection via eSource enabling tablet-based direct data capture and electronic health record (EHR) integration with a fully consolidated clinical trial workflow.
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Optimize clinical data collection and reporting
The US Food and Drug Administration (FDA) mandates direct use of eSource for clinical research in regulatory submissions.
With eSource, we focus on electronic data capture (EDC) efficiency, reducing data queries and monitoring time. With resources being stretched every year, optimizing eSource to achieve clean trial data is now essential for success.
Benefits include
- Improving the employee experience for clinical personnel and investigators with minimal discrepancy management, reduced SDV, improved overall data quality and near real-time data access for analysis and reporting
- Boosting patient engagement via eVisits and collaboration portals, ensuring high retention rates and low attrition
End-to-end data standards management
Most clinical data standards management solutions currently available are either suboptimal or lack end-to-end integration.
Our enterprise medical device regulation (MDR) approach covers every stage, from protocol to submission, with built-in traceability.
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End-to-end data standards management
Business challenges stemming from conforming to the FDA’s CDISC standards often result in delays in study design as well as in data acquisition for meaningful analysis and reporting.
The entire process is protracted, while 360-degree process workflows and collaboration tools are often absent. This extends study setup and execution timelines, significantly raising costs and resulting in unmet business needs for pharma and CROs.
Our solution is a comprehensive standards management suite for clinical data covering every stage from protocol to submission with built-in traceability. We embrace a metadata-led model in order to successfully fine-tune protocol design, study setup, data collection, analysis and creation of submission-ready deliverables.
Services and solutions:
- Astute protocol design: Including only those procedures required to extract clinical outcomes relevant to a trial’s statistical and clinical analysis.
- MDR and analytics-driven approach: Reducing amendments, data transformation and submission to improve overall quality, efficiency, cycle time and costs.
- Reinforced compliance: Operations aligned to sponsor and regulatory requirements.
One-stop solution for CDISC data transformation
Most clinical data conversion tools cannot quickly accommodate the requirements of the FDA's CDISC norms.
Transform data from multiple sources, aligned to industry or proprietary targets inspired by the CDISC.
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One-stop solution for CDISC data transformation
Data-Integration-as-a-Service (DIaaS) is a blend of product-specific features and the experience gathered from 500+ studies. It is the ideal solution to help transform clinical study standards and generate submission-ready deliverables.
DIaaS is CDISC-registered and supports all established standards, including: ODM, CDASH, STM, ADaM and BRIDG.
DIaaS has four key components:
- MDR — Comprehensive metadata repository with a built-in library of corporate, therapeutic and study-specific standards. It provides lifecycle management of metadata, versioning and up-versioning which allows building the knowledge base over time.
- DSP — Data standards platform that provides a visual graphical user interface (GUI) to map source-to-target standards with minimal programming required. It also includes auto-mapping and transformation based on MDR library and auto-creation of submission packages (SDTM annotated CRFs, Define.XML and SAS code, among others).
- CDMS — Clinical discrepancy management systems with data validation libraries containing edit checks for discrepancy management. It ensures comprehensive validation with OpenCDISC and additional custom checks.
- EMS — Clinical event management systems that incorporate lifecycle management, event workflows and notifications with end-to-end traceability and data lineage.
Accelerate clinical development
From discovery through development and to launch, an average drug costs over $1B to bring to fruition.
Our integrated clinical platform adopts a unique model based on cutting-edge components to architect an orchestrated offering for clients.
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Accelerate clinical development
Typical pharma companies use between 7 and 25 different systems across the clinical development process flow. This causes several inefficiencies while adding to the cost of drug development.
Our solution transforms the clinical landscape with best-of-breed integrated platforms to enable the orchestration of the multiple capabilities required for efficient management of clinical trials.
- eSource: Tablet and device-based direct data collection and integration with electronic data capture (EDC).
- Clinical Data Standards: “One-Stop Shop” metadata-driven clinical standards management solution from protocol to submission.
- mHealth/IOT-enabled patient engagement: Patient-centric ‘connected’ clinical trials.
- IDMP: A flexible approach to end-to-end IDMP standards implementation.
- Clinical Analytics: Extracting insights from data using analytics/AI/robotics.
Success Stories Highlighting Our Work with Biopharma Companies
Learn how HCLTech has impacted biopharmaceutical companies around the world.
PubMed article summarization tool at a North American Pharmaceutical Company
Revolutionizing efficiency and unlocking 95%-time savings with Generative AI
Building rapid innovation GenAl Lab for a Global Pharma Firm
Exploring new horizons of efficiency and reliability with responsible Al
Hybrid cloud strategy deployed for a global healthcare company
Our client is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier world.
Public cloud strategy deployed for a global pharmaceutical company
The client has embarked on an ambitious transformation to become a leading medicine company powered by digital technologies and the cloud.
Accelerated digital transformation journey for Merck
Merck - a global multinational pharmaceutical company headquartered in the US.
Accelerating innovation and improving patient care for a pharmaceutical company
HCLTech enables patient-centric approach through an integrated platform
A multinational pharma optimizes clinical trials
Our concierge services facilitate a seamless patient experience
Cloud migration for a leading pharma IT firm
Supporting end users in the cloud and maintaining compliance guidelines
A mixed reality solution for a global biopharmaceutical leader
Optimize operational efficiency using mixed reality
Reducing biopharma supply chain delays to maximize customer satisfaction
We helped a global biopharma leader overcome supply chain disruptions, enhance compliance and cut lead times for enhanced customer satisfaction.
Empowering a major player in life sciences with data modernization on AWS
We delivered cost savings, performance improvement and a future-proof infrastructure for a leading American biopharmaceutical company specializing in drug discovery, clinical trials, etc.
Scaling device distribution for Medidata from 1.5K to 10K+ per month
HCLTech provided a robust delivery model for the client
Making a Name Among Analysts
Leader in Everest Group’s Life Sciences Digital Services
HCLTech positioned as a Leader in Everest Group’s PEAK Matrix® for Life Sciences Digital Services 2022
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