Clinical Data Management
At SafeVig, We Empower Seamless Collection, Validation, And Meticulous Data Preparation, Setting The Stage For Robust Statistical Analysis In Clinical Trials
Clinical data management (CDM) is the process of collecting, managing, and analyzing data generated during clinical trials or healthcare research studies. It ensures unwavering accuracy, uncompromising integrity, and unwavering confidentiality throughout the entire lifecycle of clinical data.
At SafeVig, we recognize the pivotal role of this stage in clinical research, as it yields impeccable, trustworthy, and statistically validated data for clinical trials. Our adoption of innovative data management approaches enhances data integrity, quality, and accountability within our process. We adhere to rigorous standards and employ robust governance systems to ensure data excellence while minimizing turnaround time. Moreover, we provide tailored solutions encompassing diverse clinical data management techniques, such as personalized Case Report Form (CRF) design.
At SafeVig, our proactive team excels in identifying pain points, effectively communicating them to our customers, and delivering tailored solutions to ensure the submission of top-tier data to regulatory agencies. Our ultimate goal is to provide high-quality data with minimal or no missing values and subjectively acceptable levels of variation that uphold the integrity of statistical analysis conclusions. Our comprehensive data management solutions, crafted through meticulous outsourcing models, cater to diverse therapeutic areas and clinical trial phases, leveraging our extensive expertise.
SafeVig upholds an unwavering commitment to excellence, offering cost-effective, high-quality, and industry-leading data management services. Our experienced team possesses expertise in both paper-based and electronic Case Report Form (eCRF) investigations. Moreover, we readily adapt to the utilization of Sponsor-specific data management tools. Regarding delivering superior quality outcomes, our robust Standard Operating Procedures (SOPs) position us as formidable competitors to industry leaders.
Our expert data management staff possesses the capability to proficiently handle multi-center, multi-country research projects, adeptly managing data in both electronic and paper formats. Furthermore, we excel in a wide range of Data Management activities, including but not limited to
Database Design
Data Management Plan
Data Entry, Verification, and Validation
Double Data Entry (paper CRF)
Coding in MedDRA and WHO DD
Query Resolution and Database Lock
Design Safety Database
SAE Reconciliation
Electronic Data Integration
Customized Data Listings
Coding Service
At SafeVig, our team of seasoned scientists utilizes their extensive expertise and cutting-edge facilities to assess the safety and efficacy of your compounds. We guarantee that the testing process is rigorously controlled through detailed testing protocols and stringent controls, providing reliable and high-quality data you can trust.
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