Pragmatic Implementation of Clinical Trials

  • Post category:Blog Post
An Indian generic pharmaceutical giant was keen on developing in-house biosimilars to expand its portfolio in the domestic as well as global markets. Being a late entrant into a highly competitive biosimilar market with no infrastructure and experience, faced an arduous road ahead for making it to market in time to attain market share

Solutions We applied a comprehensive and customized Regulatory & Clinical strategy coupled with a systematic and innovative approach, efficient program management with operational excellence and risk management to enable the company achieve its target timely with limited resources.


We successfully completed Phase I trial for the biosimilar and were able to receive both Regulatory and Ethics committee approval for 5 countries and ~45 sites for the Global Phase III trial of the same molecule.

Risk Management

Four major risk management components were identified and actively monitored and managed.

  • Patient Safety
  • Ethics and Regulatory Requirement
  • Quality
  • Efficient Stakeholder Management

The Combination Approach

Clinical costs and quality of data are major concerns apart from patient safety for any global biosimilar program. For choosing a globally reputed CRO, cost becomes a limiting factor. While quality becomes a concern, most of the time, if local CROs are chosen for global programs, unless they have the global perspective, experience. However, it is impossible to ignore the fact that a god Local CRO understands the pulse of the ground much better than the global one. Hence to combat both, we recommended a combination approach of using a global CRO as monitoring & strategic partner and a local CRO as a trial execution partner. The twin benefits of the combination approach are that it reduces the overall CRO cost by ~15-20% while ensuring high quality data. Expertize and brand equity of the Global CRO could be leveraged while maintaining compliance to global quality standards at a reduced cost.

Enabling Patient Safety

Patient Safety forms the backbone of all operational and trial strategic guidelines. For ensuring the same we took additional measures, including but not limited to below:

  • Clinical trial batches were manufactured in cGMP & released by independent EU QP.
  • Stage wise sentinel dosing performed for Initial safety evaluation for Phase I study.

Smart strategy

Within global developmental program for the product, projects were executed in parallel (where possible) to reduce time to market. Also stringent risk based monitoring of the trial on periodic basis was performed. This enabled efficient and regular communication between stakeholders to maintain  alignment, proactive identification of bottlenecks and quicker resolution by collaboration, thereby reducing the overall time for the study

Developing the Overall Regulatory and Clinical Strategy for the Product

Owing to late entry into the biosimilar development, time to market became a critical driving force behind the program’s overall strategy. Since this was first molecule developed in-house by the company, considerable resources both in terms of capital and man power has been pumped into the program. Hence, it came under high scrutiny from the top brass of the organization. Along with it, since this was the company’s first asset into the biosimilar space there was low equity in the market and among the investigators & regulators. In a prevalent, highly competitive trial conditions, this further added to the difficulties of the program.

Global vs. Local Approach

Choosing the correct approach would quintessentially form the foundation of the program and enable establishment of clear guidelines for the development of the program. Based on the mandate by the senior management, competitive landscape, inherent capability analysis, regulatory requirements, feasibility and budgetary constraints a unique approach of One Product, One Dossier and One Standard was recommended.

Our designed approach enabled the company to provide a global standard product to all markets which mandated high level of quality of data, thereby generating credibility and equity among the stakeholders for the respective asset. At the same time it brought value to the customers as the company’s mandate for very low pricing to customers’ required disruptive innovations to be a part of the overall program strategy.

Global approach avoids need for redoing studies, essentially saving overall time and reduces cost of clinical trials through modular approach and provides faster access to market.


Penalty and reward clauses were inbuilt for recruitment in CRO agreements to ensure our

partners remained motivated towards faster recruitment. Regular monitoring and inter site competition was incorporated in strategy to enhance recruitment

Stakeholder Management

Biosimilar clinical trial served as a learning experience to the generic mind-set of the sponsor which was entering into in-house biosimilar development for the first time. This was achieved via active and regular communication across the organization at conception of the program to ensure alignment on the program to enable smooth execution.  All identified bottlenecks were resolved quickly with a sense of urgency and these were recorded to be utilized as learning’s for the team

Our Success Story

Thanks to our concerted efforts we successfully completed the Phase I trial and gained swift regulatory and ethics approvals for Phase III trial of

the same molecule in 5 countries (India, South Africa and Eastern Europe) along with Ethics Committee approvals for 22 sites with considerable savings while achieving all milestones timely

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