Offline Website BuilderGunvatta's Life Sciences services are meticulously crafted to ignite and accelerate innovation across the entire spectrum of clinical research activities.We provide a comprehensive, end-to-end partnership for your clinical trials, from initial data collection and profound data exploration to robust reporting and seamless integration. Our dedicated team of experts brings a wealth of knowledge and unwavering support to every phase, ensuring your research journey is efficient, insightful, and successful.
Our extensive experience is a cornerstone of our success, encompassing deep proficiency with Electronic Data Capture (EDC) systems, adherence to critical CDISC standards, expert navigation of Health Authority submissions, and the creation of compelling data visualizations. We are passionate about applying groundbreaking, innovative techniques to champion standardization and automation throughout the research process.
This strategic approach dramatically reduces the time it takes for vital new drugs to reach the patients who need them most, transforming discovery into delivery with unparalleled speed and precision. Partner with Gunvatta to unlock the full potential of your clinical research and make a tangible difference in global health.
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.
DB Build/CRF/CRF Guidelines | DMP/DTA/DTS
Study Management | DBL/Closeout
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.
Study Design/Sample Size Analysis/CSP | SAP Development/Mock Shells
Event Prediction | Review of Key Analysis Specifications | High-Level Document Review | Adaptive and Bayesian Designs
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.
Study Setup Support | CDISC Compliant Datasets (SDTM/ADaM)
TFLs/In-text | Safety Narratives | DSMB/IDMC | BIMO | Project Management | eCRT Packages | PK/PD Programming | Adhoc Analysis
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.
Integrated Summaries of Safety (ISS) | Integrated Summaries of Efficacy (ISE) | ISS SAP Development | Project Management | Regulatory Support Experience with RTOR/ORBIS
We can help you achieve corporate goals and provide the following advisory and implementation services:
Standards and Macro Development | Publishing Support | Payer Analysis Real World Evidence Data Analytics | Data Quality Dashboards
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