Welcome to Akesis

“Quality is not an act, it is a habit.”

Aristotle                                     

Akesis is a quality driven contract research organization providing dermatology clinical research services, program management, and regulatory affairs services to pharmaceutical, device, generic, formulation development and biotech companies.

The Akesis Quality Management System starts at contract signing. Our Quality Control and Risk Management Procedure defines the operational systems and processes to be established in order to ensure the quality of clinical study conduct, the accuracy and integrity of study data, and compliance with Good Clinical Practice (GCP) procedures; including the requirements for documenting the testing, checking and inspection of conformity to standard operating procedures, specifications outlined in study protocols, and regulatory or statutory requirements governing the conduct of clinical studies.

Each Akesis Clinical Study starts with a Risk Management Plan designed to identify opportunities and mitigate the risks that could impact your trial. The Akesis Quality Management System ensures high quality and most importantly reliable results that will be used as part of your application.

We specializing in NDA, primarily 505(b)(2), and ANDA programs. Akesis facilitates obtaining regulatory approvals by delivering high quality clinical and regulatory strategies, solutions and services, with the demonstrated ability to save our clients time and money. Akesis' service offering includes the full spectrum of program management, clinical, data management, analysis, regulatory, plus compliance and audit services.

Akesis leverages its access to well renowned researchers, regulatory personnel, and facilities, in North America, Central America, Europe, and Asia, to achieve unparalleled scientific, clinical, and business results while reducing the time of development and approval that significantly lowers the costs to our clients. We have dedicated personnel and contractors working in all aspects of drug development including clinical operations, data management, biostatistics, medical and scientific affairs, quality assurance auditing, regulatory affairs, and various aspects of commercialization.

The executive management team of Akesis comprises individuals who have a proven track record with regard to providing clinical development services to the pharmaceutical, generic and biotechnology industries. Each member has more than 15 years of experience in drug development, including leadership positions in the contract research, pharmaceutical, generic and biotechnology sectors.