1MED
Redefining CRO Services for Medical Device and Pharmaceutical Companies

Pharmaceutical companies opt for the expertise of contract research organizations (CROs) over in-house research teams or academic collaborations to effectively address their clinical research requirements. CROs offer numerous advantages, including specialized knowledge in specific therapeutic areas, costeffectiveness, global outreach, and expedited delivery of new medications and therapies to patients. They demonstrate high efficiency and a systematic approach, utilizing standardized operating procedures and quality management systems to effectively engage with competent authorities and notified bodies.

However, CROs typically do not delve into the specifics or technical aspects of quality controls in manufacturing processes, the evaluation of preclinical tests, in vitro tests, and in vivo tests, or the state of their equipment or precursors. These aspects necessitate a thorough technical assessment before entering the clinical realm.

“Our key differentiator is that we are technical people. In our organization, we prioritize understanding the technology and the regulatory framework to ensure our client’s success in gaining marketing approval,” says Enrico Perfler, founder of 1med.

1med, a full-service CRO and regulatory and quality consultancy company, comprises skilled professionals from various industries, including medical devices, pharmaceuticals, clinical research, and regulatory affairs. The expertise and experience of these professionals enable the company to assist the medical device and pharmaceutical industry by providing regulatory guidance, digital solutions, and full-service CRO assistance that emphasizes innovation, scalability, and customizability.

1med prioritizes understanding the technology and challenges faced during the manufacturing, verification, and validation process of medical devices. Leveraging its proficiency in these areas, the company successfully takes products from the initial concept stage to the final implementation in healthcare settings. This is particularly relevant when working with startups, as they often have strong scientific expertise but face challenges in areas such as regulatory compliance, verification, and validation—all crucial for project success. These aspects are pivotal in realizing the project from an idea or patent and in securing necessary funds through private equity or venture capital to materialize the project.

To facilitate this process, 1med has developed a program called the 1med accelerator. In this program, a project leader, known as an asset manager, is assigned to a client, serving as the main point of contact between clients and 1med’s team. As part of this program, 1med develops a plan and determines the essential actions required to progress a project from the initial concept stage to the preclinical, validation, and finally, the clinical phase. The program ensures assistance throughout the process, guiding clients in determining the necessary tests and clinical studies required to advance their project and guarantee the product’s safety and expected performance according to usage guidelines. It also offers assistance in designing the clinical study for registration and provides hands-on support throughout the entire phase of the clinical investigation. This includes collaborating with the client to prepare necessary documentation, collect data, and facilitate the implementation and execution of the clinical investigation. The 1med accelerator program can benefit not just small and medium enterprises but also medium to large companies as it can be customized for specific projects.

1med is committed to improving its capabilities and offering unparalleled support to clients in obtaining product approvals in the United States. This involves recruiting individuals with FDA expertise, strengthening its regulatory team, and establishing local partnerships to support clients in conducting clinical investigations.

This approach reduces the likelihood of encountering failures and ensures more dependable timelines. In addition, the client can expect a reliable and strong strategy. The company aims to collaborate closely with companies to enhance their innovation initiatives and contribute to their investment success. It has partnered with Accenture to leverage their competence in digital transformation and process automation to develop innovative AI software. This software, in the development stage, will enable efficient data collection, automatically analyze the data, and generate necessary documents. These capabilities will assist in meeting regulatory requirements and facilitate product certification, marking a significant breakthrough in this industry.

Our key differentiator is that we are technical people. In our organization, we prioritize understanding the technology and the regulatory framework to ensure our client’s success in gaining marketing approval

1med’s team plays a crucial role as it is vital in a business that revolves around humans. The success of the clients’ projects significantly depends on the team’s technical proficiency, dedication, and commitment to their work. It is essential for them to align with the company’s vision and mission while also acknowledging the precise requirements of their clients. Consequently, candidates must exhibit passion and dedication, as their work can, at times, be all-encompassing.

1med aims to empower businesses that share its philosophy of growth and constant improvement to bring sustainable solutions to market, improving patients’ quality of life and making a positive impact in the healthcare industry.