Bioavailability and Bioequivalence Services Clinical Data Management Central Reference Lab Clinical Trials and Research Site Management Services     CLINICAL DATA MANAGEMENT   We provide a wide array of data management, biostatistical and clinical information services to help pharmaceutical, biotech, medical devices and R&D organizations to fulfill their research and regulatory needs.      Our services include:    . Clinical Data Management    . Biostatistics and SAS programming    . Clinical information and Medical Writing    . Pharmacovigilance    . Coding and Dictionary Management . Laboratory Data management . Radiology and imaging . ECG Core Labs . PK/PD Analysis . Consulting and Project Management   DATA MANAGEMENT   We provide comprehensive data management services in pre-clinical, bio-equivalence, phase I-IV clinical trials, remote radiology and cardiology. Our goal is to transform raw data into consistent, accurate, reliable, trial output in compliance with regulatory guidelines. We are dedicated to serve you as your partner with total commitment to the success of your clinical development program. Our focus is to expedite the regulatory submission process and shorten timelines through innovative thinking and uncompromising quality.   Our services are used by pharmaceutical, biotechnology, device, diagnostic and research organizations. We have the capability to manage multi-centric studies, for domestic and global requirements in different therapeutics areas.   Our team comprises of graduates and post graduates in medicine, pharmacy, engineering, science and dental sciences with years of experience in clinical data management. We work in close collaboration with biostatisticians, research coordinators, clinical staff, regulatory and safety teams to ensure timely project deliverables.   The teams' expertise includes designing, managing and analyzing data from safety, efficacy and epidemiological studies. We can participate directly in your data safety monitoring boards and interact with various partners, including sponsors, health authorities, and other CROs. We have proven processes and systems for managing projects in either your database or our own database.   We offer our clients diary cards printing option and coordination. We work with a select group of printing vendors to handle every aspect of the study's printing requirements. This involves working closely with your team to create strategies and alternatives that help you meet your project targets error free on time every time.   BIOSTATISTICS   Our Biostatisticians have the experience to support you in all phases of clinical trials. We have the expertise to develop study designs, analysis methods, interpretations and support the overall clinical development program. Our experienced team of writers ensures that your regulatory submission documents are clear, concise, scientifically as well as medically accurate, and fully compliant with all applicable ICH and regulatory guidelines.      Our Biostatistics services include:    . Sample size calculations    . Randomization    . Writing statistical sections of the protocol    . Statistical analysis plan development . SAS programming for statistical analysis . Performing interim analysis . Preparing statistical reports and statistical   sections of clinical study reports   CLINICAL INFORMATION   Our clinical information team consists of experienced professionals who can support your clinical development program with reliable advice on trial design, protocol development and medical writing. We understand your need for fully integrated clinical study reports, incorporating all investigators' and client's requirements, while adhering to regulatory authorities and ICH Good Clinical Practice guidance. Our medical writers are involved in every stage of the study to ensure a comprehensive understanding of the study. We strive to make our reports insightful, accurate and as per regulatory requirements.   QUALITY AND PROJECT MANAGEMENT   We work with industry-standard data management tools such as Oracle ClinicalT, SAST, WHO-DD, MedDRA, nQuery Advisor, Winonlin, ARK, Clinone for consistency and accuracy.   Each project is supported by our integrated quality management systems that ensure the use of standardized processes, technologies and training. We continuously capture and analyze performance metrics on various CTQ (Critical To Quality) attributes to ensure the success of your program. Six Sigma principles are practiced to manage complexity through detailed analysis, planning, measurement and management at all stages of project lifecycle.     For more details please email : cdm@acunovalife.com

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