The healthcare regulatory services market, vital for licensing and drug/device development, is evolving significantly today. Here, the healthcare sector's dynamic nature greatly emphasizes the integration of regulatory considerations early in the product development lifecycle to prevent delays and deviations, particularly as startups increasingly seek regulatory guidance during program conceptualization.
This is where Vibrance Clinical Research employs a distinctive and comprehensive approach in crafting clinical development and regulatory strategy plans for life sciences and healthcare organizations. The company’s commitment lies in being more than just a service provider, wherein it functions as an extension of its clients' teams who work collaboratively as partners. Vibrance Clinical Research’s consultative approach is rooted in clinical and scientific expertise which guides clients not merely through the execution of requested services but also delves into the rationale behind their objectives.
“We actively engage in the design and development phase, questioning and advising on the most effective paths to achieve desired endpoints. This goes beyond a transactional service model, wherein we seek to ensure that the services provided align with the overarching goals of the client's program. As a team of medical and scientific professionals, we integrate medical and scientific considerations into our regulatory science approach,” states Dr. Surinder Kher, Founder Director at Vibrance Clinical.
“We adopt a design thinking mindset, focusing on understanding the end product's objectives, market needs, and the problems it aims to solve. This approach sets us apart in the industry as it emphasizes strategic planning and developmental insights. While we do facilitate licensing and approvals, our primary emphasis is on strategy and clinical developmental planning. We guide clients on how to approach the market, addressing the fundamental questions surrounding their program's purpose and its impact on the healthcare landscape. This differentiation underscores our commitment to delivering strategic value beyond routine regulatory procedures,” he adds.
Meeting Diverse Requirements with Optimal Due Diligence
Vibrance Clinical Research ensures a streamlined and ethical Institutional Review Board (IRB) process for clients who are engaged in clinical trials. As a competent service provider and developmental partner, the company perfectly understands the critical role of IRBs and ethics committees in the clinical trial lifecycle. Its approach involves meticulous planning to align with the specific requirements of each IRB or Ethics Committee associated with the institutions where trials are conducted.
Furthermore, Vibrance Clinical Research leverages its extensive experience working with diverse hospitals and centers to anticipate and address specific compliance needs at different locations. And when it comes to preventing potential challenges or delays, the company prioritizes thorough documentation and understanding of each committee's expectations. This includes proactively addressing anticipated questions and concerns, saving valuable time during the review process.
“Our team, which includes professionals with in-depth expertise on IRBs, is well-versed in tailoring strategies to meet the distinct requirements of various clients. And when it comes to handling challenges or deviations, we employ a strategic approach by tracking essential elements for each IRB and anticipating potential differences in their processes. This involves having contingency plans in place, such as data backup strategies, to mitigate any obstacles that may arise.
Furthermore, our SOPs are designed to accommodate variations in requirements, ensuring flexibility without compromising compliance. Ultimately, our commitment is to navigate the complexities of the IRB processes efficiently, maintaining ethical standards, and addressing challenges with strategic foresight and adaptability,” highlights Dr. Shirali Raina Labroo, CEO at Vibrance Clinical.
Expediting Regulatory Approvals & Ensuring Utmost Compliance
Vibrance Clinical Research employs strategic approaches to expedite regulatory approvals and ensure compliance, thereby ensuring successful product development. The company’s methodologies are always aligned with the regulatory landscape, focusing on efficiency and anticipating challenges. By closely monitoring subject expert committee meetings and events, it determines optimal submission timings and anticipates potential requirements. Additionally, the company analyzes past interactions which aids in predicting and addressing queries during the approval process. Furthermore, adopting a consultative and strategic planning approach from the protocol design stage, Vibrance Clinical Research provides in-depth insights to clients which prevents extensive need for modifications later.
Adding to aforementioned aspects, Vibrance Clinical Research maintains a needed flexibility with buffer periods for complex protocols, thereby accommodating additional meetings without compromising timelines. Internationally, the company is well-informed about specific regulatory requirements, particularly in the Asia Pacific region, thereby ensuring a tailored approach for diverse client’s needs. Moreover, the company has always been abreast of changing market trends and technological advancements. All of this is ingrained in their operating procedures, enabling them to seamlessly adapt to the ever-evolving regulatory landscapes.
Hence, this comprehensive and anticipatory approach positions Vibrance Clinical Research to navigate regulatory challenges efficiently, accelerating approvals and contributing to successful product development.
Staying Ahead of the Regulatory Curve
Vibrance Clinical Research proactively stays ahead of regulatory changes, ensuring alignment with the evolving landscape through a multi-faceted strategy. Internally, diligent monitoring by audit and quality assurance teams tracks alterations in guidance documents and regulatory frameworks. This systematic approach ensures compliance with the latest standards, especially in technology and MedTech-related guidelines.
Moreover, key team members actively engage with industry organizations like FICCI on pharma and clinical research to foster dialogue with regulatory bodies and gain firsthand insights. The company also participates in government initiatives and collaborates with other pharma and research associations to enhance understanding which enables proactive adjustments to services. Adding to it, individual efforts, such as involvement in industry committees and expert roles with funding agencies, complement institutionalized processes. Further to note, the company’s established protocols incorporate newly published guidelines from regulatory agencies, the DBT, and ICMR into standard operating procedures.
This ensures consistent alignment with current regulatory requirements. Moreover, the company believes in carrying out regular updates and modifications in its approaches to consider changes in biosimilar guidelines, medical device laws, or any regulatory amendments. Vibrance Clinical Research is also committed to institutionalizing a culture of continuous monitoring and adaptation, providing clients with compliant services that anticipate and address emerging challenges in the dynamic regulatory environment.
Vibrance clinical’s consultative approach is rooted in clinical & scientific expertise which guides clients not merely through the execution of requested services but also delves into the rationale behind their objectives
Going Above & Beyond
Vibrance Clinical Research specializes in supporting clients in the life sciences and healthcare product development, particularly in drugs and devices. Also, import licenses and related processes are seamlessly integrated into the overall application and regulatory strategy, forming an intrinsic part of the entire development program. In strategic partnerships, Vibrance becomes intimately involved in the development program, understanding when and how to apply for test licenses, import licenses, and other relevant licenses tied to regulatory requirements. The process is dynamic, evolving alongside the product's development stages.
Import export licensing is not pursued as a standalone service but is an integral aspect of Vibrance's holistic approach to clinical development and regulatory compliance. The focus remains on the strategic and regulatory aspects, ensuring seamless addressing of licensing requirements within the larger framework. In cases requiring expertise for import export procedures in other countries, Vibrance Clinical collaborates with local partners. While leveraging local resources for tasks like customs clearance, the overall design and understanding of required licenses at different stages remain a core competency. In summary, Vibrance's approach is to comprehensively address licensing requirements as an embedded component of broader regulatory and developmental processes, ensuring a smooth, compliant flow of products across international borders within the overall program.
A Robust Roadmap Ahead
Vibrance Clinical Research envisions a strategic roadmap aligned with its unique consultative and developmental approach. The primary focus in the immediate future is on leveraging the extensive database of consultants, partners and clients cultivated over the years of its existence, particularly within the healthcare and health tech sectors in India. With the dynamic growth of the Indian economy and the thriving startup environment, the company sees opportunities for its unique service model.
Heading forward towards the next two to three years, the company’s focus would be to explore expansion into larger markets, with a specific emphasis on the United States, recognizing the global significance of the pharmaceutical and medical technology industry in these regions. The company will also be focusing on catering to the European market. The three to five-year plan of the company involves continued growth and differentiation within the Indian market, capitalizing on the burgeoning startup ecosystem. Simultaneously, the company aims to strategically position itself on the global stage and offer consultative and developmental expertise to a broader clientele in the pharmaceutical and medical technology sectors.
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