partners

Who are we?
Emmes is a full-service, global Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation. In partnership with leading researchers, our expertise in infectious diseases, vaccines, ophthalmology, oncology, neurology, substance abuse use disorders and maternal and child health, tackles human health challenges throughout the world. The Emmes team of 1,000+ experienced professionals have provided the full range CRO expertise necessary to conduct 2000+ clinical studies for 40+ years with offices throughout the US, Europe, Canada, and India. Emmes offers a robust suite of services for Phase I-IV clinical trials, registries, and other clinical research initiatives. These include: statistical design and analysis; protocol development; data management; investigator, site, and patient services; safety and pharmacovigilance services; regulatory affairs support; EDC via Veridix AI’s Advantage eClinical; medical writing; and quality assurance.
With NeoVasculostop Emmes’ goal is to prepare a phase I human clinical trial for the lead compound and to organize all information penetrated during work on our objectives in a way that meets all the requirements for the clinical trial application to be submitted to regulatory authorities.
In preparing for a phase I human clinical trial of a lead compound, Emmes will compile all data generated by other members of consortium and draft documents for the phase I clinical trial application. Tasks include dissemination of all relevant information about lead tested compound concerning design, synthesis, testing, and stability into clinical trial application. The lead compound is selected through in vivo and in vitro experiments, followed by preclinical efficiency, safety, and toxicity tests.
The investigational medicinal product dossier (IMPD) will summarize the lead compound’s properties, stability, and synthesis route. Preclinical study reports will be reviewed and serve as a basis for clinical trial phase I documentation. The clinical trial design will be based on preclinical data, determining dosing regimens, dose escalation strategies, and the number of trial arms and volunteers. Study protocols, electronic case report forms, and all required documents will be prepared.

Our Team
Emmes places a strong emphasis on investing in their people, technologies, and processes, fostering a culture where every team is empowered to make significant contributions. The company’s commitment to data accuracy, integrity, security, and timeliness enables their teams to derive meaningful insights and meet study objectives efficiently and cost-effectively.
For the NeoVasculoStop project, key team members include regulatory, medical writers and data management experts. These experts will provide guidance on regulatory and clinical research study schedules, enhancing the probability of success by implementing novel approaches to optimize the product development timeline.