Amandeep Kaur Sehmi

Managing Director

The escalating ubiquity of chronic life-threatening diseases like cardiovascular disorders, diabetes, orthopedic conditions, and more; has propelled the need and demand for clinical trials in India. This surge in demand is fuelled by advancing and upcoming developments in medical technology and the need to assess new treatments effectively and efficiently. Regulatory agencies worldwide are continuously refining guidelines to streamline trial processes, ensuring patient safety, transparency in reporting, and cost-effectiveness which further adds to higher demand. Conducting clinical trials in India's market presents an opportunity for global companies to enter new territories.

Notably, the growth of clinical trials in India is spurred by advancements in genomics and molecular biology, driving a shift towards personalized medicine approaches that tailor treatments based on patient's genetic profiles, optimizing effectiveness. Technological progress has facilitated decentralized and virtual clinical trial models, improving patient recruitment and retention while reducing logistical challenges. The COVID-19 pandemic has further catalyzed change, accelerating the adoption of diverse trial methods and emphasizing the importance of adaptive trial design.

However, challenges persist. Medical device manufacturers often grapple with navigating complex regulatory landscapes across different countries. Compliance, quality management, post-market surveillance, and intellectual property protection are paramount concerns. In this landscape, Bioexcel stands as an experienced leader, offering expertise in regulatory navigation, quality management, post-market surveillance software, intellectual property protection, and clinical trial support. As the clinical trial landscape evolves, Bioexcel remains dedicated to helping manufacturers navigate challenges and seize opportunities within the dynamic realm of medical technology.

A Pioneer Firm

Bioexcel serves as a dedicated Contract Research Organization in the Medical Device sector, providing comprehensive support to medical device manufacturers throughout their clinical trials and research endeavors. With a team of passionate and experienced experts in medical device studies, Bioexcel ensures the highest quality results and real-world data to evaluate device and patient safety. The company possesses specialized proficiency in orchestrating clinical trials tailored for medical devices, working towards facilitating strategic client development through pre-clinical, regulatory, and post-market clinical studies within the medical device industry.

“Our mission is for safe and effective medical products and new technology for human good. We understand the unique challenges and regulatory requirements specific to medical devices, and specialized experienced teams worked for medical device clinical trials which set us apart from other research organizations from pharmaceutical trials”, shares Amandeep Kaur, Managing Director.

Bioexcel boasts a remarkable track record of successfully completing over 100 medical device clinical studies, encompassing a spectrum of 80 post-market clinical follow-up studies, 10 pilot studies, and 25 pivotal studies. These studies span diverse domains such as ophthalmic, orthopedics, imaging, dental, ENT, SBMD, IVD kits, assessments, neurological, surgical sutures, IUD devices, and more. Catering to FDA, EMEA, and Indian markets, Bioexcel stands committed to the timely and budget-conscious execution of clinical trial projects. The company adheres rigorously to regulatory compliance standards, including ISO 14155:2020, ISO 9001:2015, and ICH-GCP, enabling comprehensive support for clinical trials across Class I, Class II, and Class III medical devices.

Promising a Range of Services

Within the dynamic landscape of clinical trials, Bioexcel Medical Device CRO offers specialized services uniquely tailored to medical device clinical research. The company’s specialized team possesses in-depth knowledge of the regulatory nuances governing medical devices, navigating complex processes set by regulatory agencies.

“At Bioexcel, we excel in designing clinical trials that cater specifically to medical devices, accounting for distinct features, intended usage, and patient demographics. Our collaboration with expert investigators, hospitals, and research centers enhances site selection and management. Overseeing data collection and monitoring, our experienced team of more than 10 Clinical Research Associates ensures the accuracy and reliability of captured data”, further shares Amandeep Kaur Sehmi.

A pivotal part of Bioexcel’s services involves post-market surveillance support, which significantly benefits medical device manufacturing companies. The firm’s distinguishing factor lies in understanding the unique realm of medical device clinical trials, encompassing regulations, tailored trial designs, precise patient recruitment strategies, and the intricacies of device-related data collection. This targeted approach reflects Bioexcel's commitment to providing efficient and customized services, guiding medical device manufacturers through the intricate journey of product development and commercialization.

Bioexcel provides comprehensive services spanning pre-clinical, regulatory, and clinical aspects tailored for the medical device industry, along with expertise in biomaterials' efficacy, safety, and biocompatibility evaluation. In the clinical realm, Bioexcel’s offerings encompass monitoring, audits, study initiation, and clinical data management. The training services encompass EC/ IRB communication, medical writing, statistical analysis plan, LOD, and other essential components. In the European regulatory landscape, Bioexcel extends support in risk management, general safety and performance requirements, and CE certification for medical devices. Complying with Indian regulatory norms, the firm facilitates services such as test and manufacturing licenses, and product classification, to name a few. In the USA, Bioexcel assists with US FDA 510k alignment and NIOSH certification, among other regulatory requirements.

Bioexcel has developed specialized software tailored for Medical Device Clinical Studies and post-market clinical follow-up. Recognizing the challenges faced by medical device manufacturers in gathering post-market clinical data, Bioexcel’s software offers a viable solution. It enables comprehensive data collection of adverse events, product complaints, safety, and performance-related information from healthcare professionals, patients, and users. The software generates comprehensive reports, conducts data analysis, and facilitates real-time monitoring for prompt response to adverse events.

Compliant with regulations like 21CRF Part 11 and HIPPA, it prioritizes data security and privacy as Bioexcel strictly follows ISO 27001:2020. The software integrates with clinical and electronic health record systems, streamlining data collection and avoiding redundancy. It supports signal detection for potential safety concerns, while customizable workflows accommodate diverse medical devices and post-market surveillance strategies. Additionally, the software fosters collaborations, connecting investigators, regulatory affairs teams, quality management, and healthcare providers for seamless global surveillance studies. The software is simple to navigate and easily scalable, capable of complex integrations, and precise for maintaining data security and regulatory compliance.

“The firm’s reputation for successful clinical trials, adherence to regulatory guidelines, and data-driven insights contribute to increased client satisfaction and attract new business opportunities. As the firm continues to demonstrate its capabilities, professionalism, and dedication to delivering results, our reputation continues to grow, leading to further expansion and business growth within the medical device industry”, adds Amandeep Kaur.

Charting the Path Ahead

“Future vision of a Bioexcel will likely be created around innovation, technology integration, patient-centric and regulatory expertise. We are more focused on PMCF & Materiovigilance activities, due to the emphasis on digital health future medical device clinical trials may involve a grated integration of digital health technologies wearable and remote monitoring devices. Bioexcel has developed Xceltrials technology (a digital platform for medical device clinical trial management) to collect real-time data and improve the efficiency of clinical trials. Xceltrials focus on real-world evidence through post-market surveillance and observational studies”, further adds Amandeep Kaur.

Embarking on a transformative journey, Bioexcel is committed to enhancing the Xceltrials clinical trial management software with cutting-edge technologies, including AI, to facilitate the implementation of virtual clinical trials. The firm’s strategic focus lies in amplifying capabilities for post-market surveillance and real-world evidence collection, empowering medical device manufacturers to amass comprehensive, long-term safety and performance data for regulatory compliance. Enabling remote patient participation from homes and local healthcare facilities is a pivotal pursuit for the coming years as well. Further, Bioexcel is venturing into new therapeutic domains, widening its clinical trial landscape across diverse specialties, and strategically expanding its presence towards the US, Europe, Australia, UAE, Africa & many more.