CPHI Pharma Awards 2023 – Regulatory & Compliance Winners: Lambda Therapeutic Research Ltd.

After another year of impressive nominations for the CPHI Pharma Awards our winners were announced at CPHI Barcelona in October. In this series of interviews, we speak to the teams behind the award-winning projects, concepts, and technologies. 

Please can you give some background to Lambda Therapeutic Research and the aims and goals of the company?

Lambda Therapeutic Research stands at the forefront of the global Clinical Research Organisation (CRO) landscape, headquartered in Ahmedabad, India, and extending its impact across Mehsana (India), Warsaw (Poland), London (UK), Toronto (Canada), Pittsburgh (USA), and Las Vegas (USA).

In 2019, we strategically bolstered our North American presence by acquiring Novum Pharmaceutical Research Services, a distinguished 50-year-old CRO. This strategic move, following the integration of Biovail’s R&D facilities in Canada in 2010, marked Lambda’s second significant acquisition in North America. Operating under the unified brand of Novum Pharmaceutical Research Services in North America, Lambda reinforces its position as a key player in the global CRO market. Lambda & Novum offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

You won the ‘Regulatory & Compliance’ prize for the advanced EDC Solution – please can you tell us a little more about this technology?

Lambda Therapeutic Research is honoured to receive the 'Regulatory & Compliance' prize for our Advanced Software Solutions and Electronic Data Capture (EDC) Platform. Our EDC platform, Biznet 8.0, is a robust paperless solution for managing end-to-end healthy volunteer studies for any sponsor. The solution is also capable of managing multiple patients with a detailed clinical history under one umbrella.

Key features of the application include:

•    A built-in integrated project management tool to track studies against the defined tasks is a key feature of the application. Sponsors can review the projected tasks versus actual performance.
•    An inbuilt Electronic Data Capture (EDC) that allows accurate, clean, and fast access to collected clinical data. Data is also collected through electronic interfaces with multiple machines used in clinical and imaging areas.
•    Biometric scanning using IRIS and fingerprint throughout the process chain – from registration, identification, and retention to ensure subject safety.
•    Wristband QR code tracking for the subject during the study for accurate data mapping.
•    Barcode-based biological sample tracking system that can handle millions of samples effortlessly.

Have you encountered any challenges in developing this platform, and how did you overcome them?

We encountered significant challenges during the development phase of our platform. Our primary objective was to transition our entire operations to a digital framework, providing a seamless and uninterrupted experience for individuals entering our premises. Given that we conduct over 250 studies annually, each with a substantial subject pool ranging from 80 to 100 subjects, capturing over 200 different body parameters before enrolment, the volume and complexity of our operations posed unique challenges.

Here are some key challenges we faced and how we mitigated them:

•    Change Management: The transition from paper to electronic processes necessitated a comprehensive overhaul of all operational SOPs, requiring meticulous change management strategies.
•    Updating Regulatory Compliance: Ensuring adherence to regulatory standards such as 21 CFR 11, Annex 11, and GDPR was a critical aspect of our platform development. We implemented robust measures to stay compliant with evolving regulations.
•    Training: Continuous training for end-users was imperative to ensure a smooth transition and ongoing operational efficiency. This was crucial to prevent any issues arising from the introduction of new digital processes.
•    Interfacing with Other Systems: Integrating our platform with various systems, including weigh machines, CNC machines, imaging machines, and other software, presented a challenge. Seamless data interfacing and exchange between these diverse systems were essential to avoid data loss and maintain confidence in the integrity of our operations.
•    Operationalising Software Across Locations: Extending the software's operational capability to multiple locations required careful planning and execution to maintain consistency and effectiveness.

These challenges were pivotal points in our development journey, and through strategic planning, rigorous training, and robust interfacing solutions, we successfully overcame them. This allowed us to create a platform that not only meets our high operational volume but also ensures the accuracy, reliability, and compliance necessary for clinical research.

How can this platform be used to help companies adhere and adapt to changing regulations globally? 

Lambda's Advanced Software Solutions and EDC Platform play a crucial role in helping companies adhere to and adapt to changing regulations globally. 

Transparency – Plan vs. Actual: The platform provides transparency through an integrated project management tool, allowing companies to compare planned tasks versus actual performance. This transparency aids in regulatory compliance by showcasing adherence to predefined timelines and tasks.

Eliminating errors – Data Transcription: By eliminating manual data transcription through the integrated Electronic Data Capture (EDC), the platform significantly reduces the risk of errors. This ensures accuracy and cleanliness of clinical data, aligning with regulatory expectations.

Scalability: The platform is designed for scalability, accommodating the high volume of studies conducted by companies. This scalability ensures that as the regulatory landscape evolves, companies can efficiently adapt and expand their clinical research operations.

Identification in cross-participation studies: The platform incorporates biometric scanning using IRIS and fingerprint technology. This enhances subject identification, particularly in cross-participation studies, ensuring accurate tracking and data mapping while maintaining subject safety.

Sample Inventory Management: A barcode-based biological sample tracking system is integrated into the platform. This feature efficiently manages millions of samples, providing companies with a robust system for sample inventory management, a critical aspect of regulatory compliance.

Electronic Pharmacy Management for Managing IMP: The platform includes an Electronic Pharmacy Management system, streamlining the management of Investigational Medicinal Products (IMPs). This feature ensures compliance with regulatory guidelines for the storage and dispensing of pharmaceuticals in clinical trials.

Our platform offers a comprehensive solution that promotes transparency, minimises errors, ensures scalability, enhances subject identification, efficiently manages sample inventory, and facilitates electronic pharmacy management. These features collectively empower companies to not only adhere to current regulations but also adapt seamlessly to the evolving global regulatory landscape.

What does winning the award mean to you and how will it help you as a company?

Winning the award holds immense significance for LAMBDA as it signifies the realisation of our vision for end-to-end digitisation and being consistently audit-ready. The vision, conceived several years ago, is now a tangible reality, with our operations fully digital and prepared to face around 50 audits annually with unparalleled efficiency.

This achievement stands as a profound validation of our unwavering dedication to excellence in clinical research and regulatory compliance. For LAMBDA as a company, this accolade significantly enhances our industry standing and reputation. It instils confidence in our partners, clients, and stakeholders, reaffirming that they are engaged with a CRO leading the way in innovation and regulatory excellence.

A heartfelt appreciation goes to our exceptional team for consistently upholding the highest standards of regulatory compliance, contributing to this remarkable achievement. 

What does the future hold for Lambda Therapeutic Research? What further initiatives do you have in the pipeline?

The future for Lambda Therapeutic Research is marked by a commitment to continuous growth, innovation, and impactful contributions to the field of clinical research. Our vision revolves around staying at the forefront of the industry and driving advancements in healthcare through cutting-edge research.

To further enhance our capabilities, we plan to leverage the advancements in technology by adding more modules to our product. This includes the integration of features such as econsent and patient diary, enhancing the overall functionality and user experience.

Additionally, we are exploring the introduction of an AI solution within our Electronic Data Capture (EDC) platform. This AI solution aims to bring a new dimension to our capabilities, offering more intelligent and efficient data capture and analysis processes.

The legacy of Lambda's dependable service will endure, underscoring our unwavering commitment to quality, reliability, and the provision of value-added services to our sponsors. This dedication continues to serve as the cornerstone of our operations, reflecting our enduring pledge to excellence in every aspect of clinical research.

Mrs Bindi Chudgar is one of the most distinguished women in the corporate world. Since inception, Mrs Chudgar's entrepreneurial intellect has ensured that Lambda grows both organically and inorganically to become a truly global CRO. Over the years, her progressive vision and values have helped Lambda create a niche to stand apart from the rest in the CRO industry. Meticulous by nature, she overlooks Lambda’s Corporate M&A, Strategy, Finance & Human Resources embracing the best of contemporary and conventional ideologies which are the best fit for the organisation globally.

Mrs Chudgar’s keenness on high-quality standards is best reflected in Lambda's exceptional regulatory track record. The organisation's various facilities across the world have undergone successful accreditations by some of the world’s topmost regulatory agencies. It is her visionary genius and strong-willed determination that helps Lambda transcend geographical boundaries to excel in the world's most promising pharmaceutical markets, besides continually augmenting and diversifying its service portfolio and expertise.

Mrs Chudgar has always been a people's person. She believes in building an engaging and empowering work culture which are the foundation and key drivers for building a strong and successful organisation.
She is determined to continue raising the bar for the development and commercialisation of new medical therapies worldwide, through Lambda.