Case Studies

An Innovative Approach to Meeting Pharma’s Changing Needs: The Shift to Functional Service Providers

The pharmaceutical industry faces tremendous challenges in the coming years: depleting pipelines, patent expirations, shorter drug-development times, and more demand for novel products that satisfy unmet medical needs. The service industry needs to provide these sponsor companies with more creative, innovative approaches and the experience and flexibility they demand. The new business model for providing this support is the Virtual CRO model.

Traditional contract research organization  (CRO)  models  have  long  been  the  choice of pharmaceutical, biotechnology, and medical-device companies for research- and-development support services. Using these models, CRO industry leaders have established global, synchronized processes; built global infrastructures; and provided a wealth of services that allow sponsor companies to take a “one-stop shop” approach to development.

Today, however, these companies are exploring new ways to leverage outsourcing so they can lower drug-development costs while rapidly delivering safe, effective medicines.

Download the following three case studies to see this model and the benefits it offers in action:

  • Case Study 1: Rescue of an oncology study from a global, full-service CRO company
  • Case Study 2: Assisting a sponsor company with investigator-initiated research workflow
  • Case Study 3: Biotechnology company with limited budget leverages Virtual CROs to  gain access to experienced providers

About the Founder, Michael Harte

Michael Harte has more than 20 years of experience in the CRO services industry.  Through his work with two traditional global CRO services companies, Harte excelled at exploiting the sponsor/vendor interface, ensuring that expectations of services and communication channels were established, leading to many years of services support for its company’s clients.

Seeing the newer trends evolve, Harte was a co-founder of one of the first electronic data collection (EDC) companies in the industry, and helped to steer the company and its clients to push the boundaries of simple data collection to an integrated platform that allowed clients to effectively use the information to effectively manage their internal and external resources.

Harte founded The Harte Group in 2009 with other like-minded industry executives who have an average of 24 years experience to assist companies who are implementing a virtual solution to their drug development challenges.