Clinical Data Management

Every successful clinical trial is built on the foundation of efficient clinical data management (CDM). At Solve labs, we've prioritized the gathering and management of clinical trial data as a core component of our entire service portfolio. Both have handled the data requirements for local, regional, and international trials and have experience in a variety of therapeutic areas.

The Functional Service Provider (FSP) relationship can be full or partial, and CDM services can be obtained either as part of our integrated service offering or under it. To guarantee on-time deliverables, our global staff makes use of our well-documented procedures and service level agreements. We manage all stages of clinical research across the entire therapeutic spectrum.

Solve labs can provide complete Clinical Data Management

Standard operating procedures
Data management plan
Database design and build
CDISC
Validation rules
User acceptance testing
Paper CRF studies
Support for EDC and Paper CRF’s
Status and tracking reports
Patient related outcomes
SAE reconciliation

jpeg-optimizer_Clinical-data-management-system

Apply Now

Advanced Certified Program in Clinical Data Management

The management and processing of the data gathered during clinical trials is the focus of the clinical data management subfield of clinical research. The cornerstone of the drug development process is acknowledged to be clinical data management (CDM). In terms of quality, accuracy, verifiability, consistency, and, most importantly, conformity to local laws and GCP, it meets the specialised requirements of the crucially important Drug Development. Clinical Trials and Drug Development both greatly benefit from CDM. It ensures the quality and integrity of the data as it is transferred from the trial CRF to the database system. The course consists of case study assignments, exercises, and theory and practical sessions. The students will gain practical experience using Clinical Data Management software and its applications during all of the practical sessions.

Benefits of joining this program

We Offer Clinical Data Management Software with eCRF Designing Real Time Experience.
course Materials will be made available, including thorough information on the Clinical Data Management workflow as a whole.
Hands on experience on Clinical Data Management Software’s used in the Industry
Practical training will be provided on eCRF designing, Data Entry, Discrepancy Management, Batch Validation, MedDRA Coding
We Offer Clinical Data Management Software Real Time Experience with eCRF Designing.
Among all training institutions, the highest placement rate
Training in industry-specific SOPs
trainers with at least nine or more years of experience

1During the training, the following course material will be covered:

Phases of Drug Development and Clinical Trials Introduction and Welcome to Clinical Data Management
Clinical Data Management Life Cycle, Clinical Research Foundations, and CRO Roles
ICH-GCP regulations
Processing and studying the clinical trial data (pharmaceuticals, biologics, or devices).
Organize the information processing and receipt for projects (e.g., coding dictionaries)
digital data collection.
Ascertain that databases are approved and prepared for transfer or analysis.
Support the Clinical Operations team and/or study project with clinical data management.
Support the biostatistics team and the clinical data management team with clinical data management.
Participate in the evaluation of documents relating to clinical research (eg. Protocols, Case Report Forms, Reports).
Create a data management plan (DMP) and maintain it for the duration of the study project.
makes sure the DMP is carried out in accordance with the specifications and design of the study.
Create a paper or electronic version of the Case Report Form (CRF).
Create database (DB) clinical trial data specifications, including eCRF design and user requirements.
edit guidelines or checks, query logic, and data validations.
Lead EDC database (DB) specification process
Create data transfer agreements (DTAs) with core labs or external data vendors.
Reconcile electronic data transfers from the vendor to the sponsor.
Create test scripts and execution logs for user acceptance testing (UAT).
Plan UAT of the eCRF build and document validation.
Edit check documents, issue logs, and UAT summary reports.
Maintain/track EDC user management and other clinical databases across allotted clinical trials.
Make sure the clinical data in EDC is suitable for statistical review, interim review, final database lock, data reconciliation, and/or coding.
help define and/or produce data listings, summary table validation, data specifications, and/or processes
Transfer data in advance of statistical analysis and/or a data management audit.
Organize the archiving of research databases and related documents.
Complete the close-out audit required for the study trial's closure in EDC or other clinical data management DBs.
Help with AE/SAE data reconciliation in Safety DB and/or other Data Management DB, including, but not limited to, performing MedDRA and/or WHO coding.
assist with and contribute to the data analysis plan for the study or project.
Documentation for Edit Check Specifications

Benefits of learning Clinical Data Management at Solve Tech Training Institute

Our experienced professionals are instructing this course.
Solve Tech provides you the facility to schedule the classes according to your availability.
Following each session, you'll receive the course material for your own future reference.
You will receive an internationally recognised certification after completing the course.