Bioavailability and Bioequivalence Services Clinical Data Management Central Reference Lab Clinical Trials and Research Site Management Services     CLINICAL TRIaLS AND RESEARCH   CLINICAL OPERATIONS AND PROJECT MANAGEMENT   Your journey of getting the drug through clinical development program is a challenging path, and at every step you can completely rely on us to deliver results on time and error free within the desired budget.   Our clinical and project management teams provide integrated planning and implementation from start to end of the study. As our partners in research you will have access to an experienced project management team that will assist you in various areas of the design and implementation of your clinical program.   REGULATORY STRATEGY AND CONSULTING   Our regulatory consulting group is experienced in the development of positioning strategies, integrated planning, management, preparation of dossiers and submission to regulatory authorities for smooth transition and conduct of clinical research in India. Our experts are experienced in effective and diplomatic liaison with regulatory bodies. We ensure fast turn-around on regulatory documents and represent/ support you in meetings with regulatory agencies, for scientific advice.      This includes:    . Review of protocol    . Preparation and review of clinical trial      applications/dossiers    . Import licenses . Effective communication with regulatory   authorities . Assistance with independent review   board/ethics committee approval   CLINICAL MONITORING TEAM AND ACTIVITIES   You can rely on our experienced project leaders and multifunctional teams who will work proactively and creatively to ensure success of your clinical development program. Each project team is headed by a project leader who manages and coordinates the activities of a multi-functional team comprising of Clinical Research Associates (CRA), Clinical Trial Associates and regulatory professionals who are known to be experts in their domain.   Our Project leaders are truly accountable for all your project deliverables, implementation, tracking and resolving all project related issues. These leaders ensure proactive identification and resolution of potential issues to keep projects on time or ahead of schedule. They coordinate with the clinical monitoring team for site management, development of site visit schedules, report preparation and review.   Our CRA's have experience under various therapeutic areas and have gone through vigorous training programs. They work closely with the project leader to ensure comprehensive planning, communication plans and project activities are documented in detail.   CLINICAL MONITORING SERVICES      Our monitoring services include:    . Investigator and Site Feasibility    . Site Selection    . Investigator's meeting . Site Initiation, Monitoring and Close out . Site Management . Query resolution   PATIENT RECRUITMENT   We understand the needs, challenges and dynamics of effective patient recruitment. Our project team and CRA's consider the impact of the following factors to blend an effective patient recruitment strategy.      This includes :    . Protocol requirements    . Competing studies    . Locations of the trials . Ethnic distribution of population . Patient demographics . Seasonal variations   Manipal Acunova offers tailored support for recruitment and retention to study site personnel. Our patient recruitment programs will speed the recruitment process and shorten the clinical enrollment timeline.   THERAPEUTIC EXPERIENCE   Our therapeutic expertise includes Cardiovascular, Central nervous system, Diagnostics, Endocrinology, Hematology, Immunology, Oncology, Ophthalmology, Orthopedics, Pediatrics, Respiratory and Vaccine research   CLINICAL TRAIL SUPPLY MANAGEMENT   Manipal AcuNova has experience in inventory management and coordination for all your clinical supplies. Our service covers the clinical supply process from consultation for clinical labeling to drug destruction in quantities ranging from Phase I to large-scale Phase III/IV studies involving multiple centers. When it comes to driving project completion, Manipal AcuNova provides unsurpassed attention to detail.      These include :    . Obtaining import/export licenses    . Import/export services and custom      clearance    . ICH complaint storage    . Dedicated walk in coolers    . Label design, printing and application    . Ambient, Refrigerated and frozen storage      and distribution . Inventory management . Study-specific randomization using   Interactive Voice Response Systems . Customized, expedient distribution solutions   for every study . Post-study drug return and reconciliation . Overall drug accountability and destruction     For more details please email : research@acunovalife.com

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