Clinical Development

At BioMDg, we specialize in developing clinical testing programs that are essential for demonstrating the safety and effectiveness of your biologic or medical device. Our comprehensive approach begins with meticulous site selection, ensuring that your trials are conducted in the most suitable environments. We assist in preparing all necessary submission materials for Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), and Ethics Committees, as well as drafting informed consent documents that adhere to regulatory standards. Our expertise extends to crucial regulatory submissions that keep your project on track. By providing this foundational support, we set the stage for a successful clinical trial process.

We also handle case report form development, including electronic data capture (EDC), ensuring efficient data management throughout your study. Additionally, we design clinical databases tailored to your project, while also creating essential documents such as investigator agreements and brochures. Protocol writing is another critical service we provide, ensuring that your study adheres to all regulatory requirements and scientific rigor. With our support, you can focus on what matters most—your research. Interested in streamlining your regulatory submissions? Contact us today for tailored solutions.