✖
Gunvatta’s Life Sciences services are tailored to facilitate and innovate clinical research activities. From data collection, exploration, reporting and integration, our team of experts will support the clinical trial till the end. We have extensive experience with EDC systems, CDISC, Health Authority submissions and data visualizations. We apply innovative techniques to promote standardization and automation that leads to reduced time in getting drug to patients.
Data management encompasses study setup, study conduct, study closeout, global library setup, data documentation & standards. An active Data Management Plan (DMP) documents the plans for the collection and management of data throughout the life cycle of a clinical trial. Gunvatta has an experienced team to coordinate the data management activities with exceptional quality and special attention to potential risks.
Experienced biostatisticians at Gunvatta utilize technology (R/SAS) and expertise and to help advance the analytical and statistical methodologies. We engage with you through our skilled thoughts and statistical techniques to improve the study design and guide you along the study from start to finish.
We leverage programming languages such as SAS, R, Python, SQL to collect, transform and report data from EDC and third-party vendors into CDISC compliant datasets and CSR specific outputs. Our team, collectively, brings 100+ years of experience in the clinical trial landscape with multiple country submissions experience. We also work with our clients to introduce automation which leads to reduction in costs.
For the marketing registration application (NDA, BLA, MAA) sponsors are required to submit the safety and efficacy information from all relevant clinical trials. These need to be designed, planned and submitted carefully to ensure informed decision-making by regulatory authorities. Traceability, conformance to standards, knowledge of technical rejection criteria etc. are key components for a successful submission. Our team has worked on multiple health authority successful submissions which includes FDA, PMDA, cFDA, EMEA and other countries.
We can help you achieve corporate goals and provide the following advisory and implementation services:
Data management encompasses study setup, study conduct, study closeout, global library setup, data documentation & standards. An active Data Management Plan (DMP) documents the plans for the collection and management of data throughout the life cycle of a clinical trial. Gunvatta has an experienced team to coordinate the data management activities with exceptional quality and special attention to potential risks.
Experienced biostatisticians at Gunvatta utilize technology (R/SAS) and expertise and to help advance the analytical and statistical methodologies. We engage with you through our skilled thoughts and statistical techniques to improve the study design and guide you along the study from start to finish.
We leverage programming languages such as SAS, R, Python, SQL to collect, transform and report data from EDC and third-party vendors into CDISC compliant datasets and CSR specific outputs. Our team, collectively, brings 100+ years of experience in the clinical trial landscape with multiple country submissions experience. We also work with our clients to introduce automation which leads to reduction in costs.
For the marketing registration application (NDA, BLA, MAA) sponsors are required to submit the safety and efficacy information from all relevant clinical trials. These need to be designed, planned and submitted carefully to ensure informed decision-making by regulatory authorities. Traceability, conformance to standards, knowledge of technical rejection criteria etc. are key components for a successful submission. Our team has worked on multiple health authority successful submissions which includes FDA, PMDA, cFDA, EMEA and other countries.
We can help you achieve corporate goals and provide the following advisory and implementation services:
We look forward to discussing how we can support you.
Thanks For downloding...
