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.
Dermatology Clinical Research
Akesis has worldwide experience conducting dermatology trials in Phase I, II, III and IV. Our experienced staff focus on the details while keeping all stakeholders informed of our progress during the clinical trial. We provide either full service offering or individual services.
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.
We have worked with partners in North America. South Africa, Germany, and Central America for Phase I and specialty dermatology studies. To compliment our full time staff, we have working relationships with industry-leading experts such as clinicians, project managers, patient recruitment organizations, clinical research associates, data analysts, biostatisticians, and medical writers with experience developing dermatology products.
We offer a broad range of expertise in topical and systemic products for treatment of a variety of dermatologic diseases and syndromes as well as studies in many different patient populations.
Acne Vulagris, Rosacea, Psoriasis, Tinea Pedis (athlete's foot), anti-fungals, eczema, atopic dermatitis.
This experience has allowed us to develop best-practice approaches to patient compliance, investigator selection, data management programming (specific to the expected number of queries, and coding), and data collection consistent with dermatology patient data. The CRAs of Akesis are knowledgeable of the anticipated types of adverse events, concomitant medication lists, and common medical history of dermatology patients; safety associates are familiar with disease-related Serious Adverse Events; and statisticians understand the data points and formatting required to generate the appropriate number of tables, listings, and figures.
Akesis has extensive experience in managing dermatology clinical studies. We have been a part of nearly 60 dermatology development programs.
The Akesis Quality Management System has been built with a "quality by design" mindset. Our clinical and regulatory experts strive to intrinsically understand what we are studying from the safety of patients to the primary and secondary endpoints. It is through this knowledge that we can anayze the positive and negative risks associated with the study and plan accordingly. The risk plan is not static and reviewed on a regular interval within Akesis and with the sponsor.