The Akesis Difference
Agility and Autonomy Through Private Ownership
As a privately owned company, we are able to be uniquely nimble in pursuit of our clients’ objectives. This flexibility helps us to maneuver efficiently through challenges and to provide an unparalleled level of responsiveness, attaining study goals as quickly as possible. We offer genuine executive engagement and participation, and leverage our experience, size, and culture in ways that provide productive, cost-effective solutions.
Unsurpassed Therapeutic Expertise
Our focus is purely dermatology clinical research and regulatory affairs. As a partner in nearly 60 dermatology clinical trials currently underway or completed, Akesis has extensive worldwide experience in topical and systemic products for treatment of a wide variety of diseases and syndromes in many different patient populations. We offer access to the world’s top researchers.
Cost-Effective Trial Management
Akesis’ proprietary processes, infrastructure and insights help clients maximize their research resources. With therapeutic clinical trial expertise in multiple areas, we customize our services to meet our clients’ needs. Our staff offers 60 years of senior leadership experience and draws upon a broad network of resources - from patient recruitment organizations to clinicians to medical writers – to deliver the efficiencies that propel trials to successful completion without cutting corners. We can provide total program development, deliver discrete services for any part of a trial, or rescue failing trials by getting timelines, budgets and enrollments back on track.
Frequent Communications With A Single, Knowledgeable Point of Contact
We recognize the importance of detailed communication, from kick-off meetings to weekly teleconferences to tracking to ensure that our sponsors are always fully up-to-date with their study progress. Every project we initiate has a Project/Program Manager directing the trial who acts as the central repository of information and provides robust communications to all stakeholders.
Exceptional Regulatory Strategy Guidance
Our team is composed of highly qualified and seasoned individuals with intimate working knowledge of the FDA. These multi-lingual, multi-national professionals provide regulatory and drug development guidance, perform submission planning and management, and advise on tactics to maximize success during all phases of your project.
Strong Site Relationships
We believe that selecting the right investigative sites directly correlates to achieving enrollment targets within required timelines. At Akesis, we cultivate and maintain an investigator network that encompasses many dermatological indications. We offer a proven approach to quality site selection and investigator recruitment, including study-specific questionnaires, feasibility assessments and expert evaluation of the potential sites to ensure a high probability of success for each study.
Experienced, Well Trained Monitors
Our project teams endeavor to be an extension of the investigative team through regular communication and rigorous monitoring and they work in collaboration with our sponsors. We deploy highly experienced CRAs throughout the world to maximize site performance and ensure that quality standards are met. Our CRAs participate in exacting and comprehensive training and are charged with providing the support necessary to effectively manage the sites. They are multi-lingual, including fluency in English, and are conversant in local regulatory requirements, an important aspect of reducing approval process timelines.
Global Scale and Scope
Akesis offers a vast global network of qualified professionals. We are intimately familiar with qualified sites in the US and abroad, offering international clinical study capability. Our associates are multi-lingual and multi-national and our strategic partners span the globe. Regulatory professionals have international compliance expertise.
We select our partners with the same rigorous performance model we use to recruit and appraise our own staff, and hold them to the same high standard. We work exclusively with renowned industry leaders, forming flexible strategic alliances that produce actionable data, enabling our clients to assess the potential of their products quickly and cost effectively, while freeing their own resources for other purposes.
Site Management Expertise
We employ consistent management practices throughout our operational universe, with everyone from our valued affiliates to our select investigative sites. This management expertise results in expedited study startup, productive patient recruitment methodologies, and consistent evaluation and assessment techniques for accurate data and metrics reporting.
Low Project Team Turnover Rates Yield Monetary Benefits
At Akesis, we promote a supportive culture of dedicated professionals who are rewarded with opportunities for continual education, peer recognition and financial rewards.As a result, we have a high employee retention rate of which we are proud.This low turnover rate benefits our clients, providing consistent quality, minimized training costs, enhanced management resources and increase efficiencies, particularly for study start up and close out."For more information, send email to email@example.com; " or call 803 831 7657 to learn more. We look forward to hearing from you