Holmes has expertise in all aspects of management, marketing and operation of the clinical research and drug development business. The group has successfully carried out complex clinical operations and trials, and maintains excellent contacts in the pharmaceutical and biotech industries. Holmes currently has active contracts with six of the top ten pharmaceutical companies in the world.

Contract Research Organization Division

The term outsourcing in the pharmaceutical and biotech industries means converting the fixed costs of maintaining the necessary personnel and infrastructure, into the variable cost of paying a subcontractor to perform that process as needed. These subcontractors for contract research are commonly referred to as Contract Research Organizations (CRO). CROs are now positioning themselves as strategic partners of pharmaceutical clients, rather than simple service vendors.

Holmes subsidiary, Qualia Clinical Services, Inc. of Omaha, Nebraska supports the global research and development needs of biotechnology, pharmaceutical and medical device companies on an outsourced basis. Services range from laboratory testing to data analysis and human clinical trials management.

Through Qualia as a CRO, Holmes BioPharma provides clinical research for two primary industry sectors.

Pharmaceutical and Biotech Industries
Qualia is an experienced provider of Early and Late Phase clinical research services. Qualia delivers consistent and high quality data with the capacity to start studies within the client's desired timelines. The company relies on a highly competent development team to supply clients with world-class consultative scientific and regulatory support, quality data and the capacity to complete studies on time.

Generics Industry
Qualia can provide early and late phase clinical research services, along with bioequivalence services. Qualia offers the high capacity, fast recruitment rates, and extensive global regulatory expertise needed to start Generic studies on time, the first time.

The clinical testing of experimental drugs is normally done in a series of phases, each successive phase involving a larger number of people. When the FDA grants a New Drug Approval (NDA), then pharmaceutical companies can conduct post marketing or late phase studies. Holmes is focused on providing both Early and Late Phase clinical research.

Drug Development Division

Holmes has a two-pronged strategy for entry into drug development and manufacturing. First, focusing on new drug development based on innovative drug delivery systems that improve proven technologies. Secondly, developing protein based generics and generic drugs based on abbreviated new drug applications (ANDA).

Holmes will utilize its research facilities and management expertise to enter into the generic industry, allowing it to develop, test and get fast regulatory approvals on generic ANDAs.