Mandava Associates provides both overall and specific expertise in all areas of project management, utilizing the latest technologies and providing facilities that best fit the individual needs of each client. The quality processes, project and knowledge management systems are teamed with a contractual and financial system which enables Mandava Associates to meet the requirements of today's pharmaceutical & biotechnology industry, for rapid and cost effective product development but not sacrificing scientific integrity.
Our senior associates personally oversee all drug development projects, from the conceptual stages through the regulatory development, preclinical design and study implementation and culminating in all the Phases of the clinical trials, all the while, keeping the governmental agencies abreast through the required submissions and reports.
Complementing the above, Mandava Associates are skilled at identifying potential problems that may arise, be they regulatory or scientific, and are experienced at developing contingency plans or conducting risk analyses, to solve these problems.
Ensures proactive identification and resolution of potential issues to keep projects on schedule and on budget
Coordinates clinical monitoring tasks such as site management, development of site visit schedules and timely project report for smooth implementation
Creates a management framework that enables technical personnel to focus on individual tasks for better quality and efficiency
Therapeutic specialty grouping for project team composition ensure planning by a team experienced in managing the specific challenges of a given therapeutic area
Rigorous, ongoing training for project teams in drug and disease management and compliance as well as protocol-specific practices assure our clients of a monitoring team with the clinical know-how to get quality results that meet timelines
Timely review of on-going study conduct to facilitate project team communication
Timely review of safety data to ensure proper assessment and handling of safety events during the trial and to facilitate quicker reconciliation of safety and clinical data