Enhanced Drug and Medical Device Programs

As a contract research solutions company we focus on improving the management of product development from the bottom up in order to save money and time. The result is a more efficient and affordable program that enables your team to create a “lean” development program that minimizes data integration, reduces project startup costs, and empowers stakeholders to make informed data-driven decisions.

Whether it is augmenting internal staff with a functional outsourcing approach or managing the program from beginning to end, we do it, and do it more efficiently.

  • Biostatistics
  • Clinical Monitoring
  • Chemistry, Manufacturing, and Control
  • Data Management
  • GCP training
  • Global Study Feasibility
  • GxP Auditing & QA Consultancy
  • Medical Affairs & Writing
  • Patient Recruitment
  • Pharmacovigilance and Safety
  • PK/PD
  • Project Management
  • Regulatory Affairs
  • Site Selection and Management
  • TEMPO™ eClinical Platform

Your medical device CRO partner

For medical devices, good engineering does not necessarily guarantee clinical or commercial success. At times, regulators and device manufacturers seem to be on opposing sides of the playing field. Regulators often contend with pressure to fast-track approvals while at the same time ensuring product safety and efficacy. On the other hand, manufacturers risk spending time and resources to develop a device, only to not receive approval to go to market.

Executing a successful market entry strategy involves navigating the regulatory approval process, designing and conducting efficient clinical trials, and adeptly evaluating the existing marketplace.


Need a Drug or Medical Device Partner?

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