Biopharma: The Future of Healthcare
New drugs, new pressures and new opportunities to lead.
The pressure on biopharmaceutical companies to deliver clinical outcomes while managing costs and regulations has never been greater.
- How do you balance R&D investments while operating at lower margins?
- How do you achieve transformational health outcomes against a backdrop of regulatory scrutiny?
When you're ready to accelerate your organization's digital transformation, our biopharma solutions help you deliver greater value and ROI in a rapidly evolving landscape. Bringing life-saving treatments to market more quickly and efficiently presents a host of challenges for most organizations — but these are challenges we've seen and solved.
Solutions that Work for Your Biopharma Challenges
Stay ahead of evolving regulatory standards with confidence
Our IDMP-360 platform provides a flexible and configurable approach to meet evolving IDMP standards, built on the industry-leading Appian platform.
This regulatory solution adapts as requirements change — so you remain compliant, no matter what comes next.
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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
Make pharmacovigilance smarter with AI
Bringing a single drug to market can cost more than $1B from discovery through launch. These high-stakes investments face even greater risk if regulatory withdrawal or recall occurs.
Our AI-powered biopharma technology enables you to monitor safety signals more effectively, allowing you to act with confidence.
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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.
Streamline your clinical data collection and reporting
The US Food and Drug Administration (FDA) now mandates direct use of eSource for clinical research in regulatory submissions. Our digital solutions make this process seamless.
With eSource, we focus on EDC efficiency — reducing data queries and monitoring time — because when resources are stretched thin, optimizing eSource to achieve clean trial data becomes essential.
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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
Master end-to-end data standards management
Conforming to FDA CDISC standards often results in delays in study design and data acquisition, which can hinder meaningful analysis and reporting.
Our comprehensive standards management suite for clinical data covers every stage, from protocol to submission, with built-in traceability. We utilize a metadata-led model to refine your end-to-end process, specifically designed with your workflow in mind.
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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.
Transform your CDISC data with one comprehensive solution
Our data integration as a service (DIaaS) offering brings together product-specific features and experiences from over 500 studies. It is the ideal biopharma data service for transforming clinical study standards and generating submission-ready deliverables.
DIaaS is CDISC-registered and supports all established standards — including ODM, CDASH, STM, ADaM and BRIDG.
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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 your clinical development process
Most pharma companies use between 7 and 25 different systems across the clinical development process, leading to inefficiencies and higher costs.
Our consulting solutions transform the clinical landscape with best-of-breed integrated platforms. We enable orchestration of multiple capabilities for efficient management of clinical trials, making your transformation journey smoother.
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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.
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
PubMed article summarization tool at a North American Pharmaceutical Company
Revolutionizing efficiency and unlocking 95%-time savings with Generative AI
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
HCLTech recognized as a Leader in Everest Group’s Life Sciences Digital Services PEAK Matrix® Assessment 2025
HCLTech has been recognized as a Leader in Everest Group’s Life Sciences Digital Services PEAK Matrix® Assessment 2025, which evaluated 35 leading life sciences digital services providers worldwide
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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Why Partner with HCLTech for Your Biopharma Journey?
Our discover-design-deliver methodology has helped biopharma companies worldwide adopt new tools in laboratory information management. When you work with us, you gain access to proven biopharma solutions that deliver tangible results.
Our ecosystem of partners provides the depth and breadth of experience you need to leverage technology advancements and prepare for the future.
10 of the top 20 pharmaceutical companies trust us as their partner
HCLTech employees dedicated to life sciences and healthcare solutions
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Frequently Asked Questions about Our Biopharma Solutions
Biopharma firms today face mounting pressures to accelerate drug development, control costs and comply with evolving global regulations. Balancing R&D investments with shrinking margins, managing complex data landscapes and ensuring patient safety are daily realities. At HCLTech, we have deep experience helping clients navigate these challenges with innovative, future-ready biopharma solutions.
Digital transformation is essential for biopharma because it drives efficiency, accelerates innovation and ensures compliance in a rapidly evolving industry. At HCLTech, we have seen firsthand how adopting digital platforms improves data integrity, reduces operational silos and enables faster go-to-market for life-saving therapies, keeping our clients ahead of the curve.
Absolutely. AI transforms pharmacovigilance by automating safety signal detection, streamlining adverse event reporting and enhancing data analysis. At HCLTech, we leverage AI-driven biopharma technology to help clients proactively manage risks, ensure drug safety and minimize regulatory actions—delivering smarter, more reliable pharmacovigilance outcomes.
We manage data standards using a comprehensive, metadata-led approach that covers protocol design, study setup, data collection, analysis and regulatory submission. Our solutions ensure CDISC compliance and built-in traceability, reducing delays and streamlining collaboration. Clients trust HCLTech to deliver consistent, high-quality data throughout the clinical development lifecycle.
Clients benefit from our global scale, industry-leading expertise and a dedicated life sciences workforce. We deliver seamless solutions across regions, leverage best practices from top pharmaceutical leaders and provide access to a broad ecosystem of technology partners. With HCLTech, clients gain a trusted partner for sustainable growth and innovation.
We improve clinical outcomes by streamlining data collection, integrating advanced analytics and deploying AI-powered monitoring tools. Our biopharma digital solutions enable faster and cleaner data capture, providing real-time insights that empower clients to make informed decisions, ultimately enhancing patient safety and trial efficacy. Our expertise ensures measurable improvements across the clinical lifecycle.
We address regulatory needs with flexible, configurable solutions, such as our IDMP-360 platform and GenAI-powered regulatory intelligence. Our approach adapts to changing requirements, automates compliance processes and ensures traceability. With decades of regulatory experience, HCLTech helps clients remain compliant, reduce risk and focus on delivering clinical value.
Our biopharma data services support clinical trials end-to-end—from eSource and EDC optimization to metadata-driven standards management and data integration as a service (DIaaS). We help clients achieve clean, submission-ready data, accelerate study setup and ensure regulatory compliance, drawing on experience from hundreds of successful clinical engagements.
Yes, we offer robust biopharma consulting solutions tailored to each client’s needs. Our experts guide clients through enterprise transformation, system integration and regulatory challenges. We draw on deep industry knowledge and proven methodologies to help clients optimize operations, accelerate innovation and achieve their business objectives.
Our partners extend our capabilities, bringing specialized technologies, platforms and domain expertise to every engagement. Together, we create integrated biopharma solutions that address complex challenges, accelerate digital transformation and deliver measurable results. Clients benefit from our collaborative approach and the combined strengths of our partner ecosystem.
