Clinical Data Management
At Paraclete Technologies, we provide expert Clinical Data Management (CDM) services to ensure the accurate and efficient collection, validation, and analysis of clinical trial data. Our services are designed to support pharmaceutical companies, biotech firms, and medical device manufacturers in their clinical trials, ensuring that all data is compliant with regulatory standards and ready for submission to regulatory authorities. By leveraging cutting-edge technology and industry best practices, we help streamline clinical research processes, ensuring high-quality data that accelerates drug and device approvals.
Do You Know?
What is Clinical Data Management?
Clinical Data Management (CDM) is a critical process in clinical trials that involves the collection, cleaning, and management of data from trial participants. The goal of CDM is to ensure that data is accurate, reliable, and compliant with regulatory standards so that it can be used to support product approvals. Effective CDM is essential for ensuring the integrity of clinical trial results and meeting timelines for regulatory submissions.
What We Offer?
Our Clinical Data Management Services
Data Collection & Database Design
We design and implement robust, customized clinical databases using industry-leading platforms like Medidata, Oracle Clinical, and OpenClinica. Our data capture solutions ensure that clinical trial data is collected efficiently and accurately from various sources, including electronic data capture (EDC) systems. 💻
01Data Cleaning and Validation
Our CDM experts perform comprehensive data cleaning to ensure that the collected data is free from inconsistencies, errors, or discrepancies. We apply rigorous validation checks and quality control procedures to maintain the integrity of your trial data. 🔍
02CRF (Case Report Form) Design
We develop precise and intuitive Case Report Forms (CRFs) that streamline data collection and minimize the risk of errors. Our CRF designs align with regulatory guidelines and clinical trial protocols, ensuring that all relevant data is captured effectively. 📝
03Medical Coding
We provide medical coding services using standardized coding dictionaries like MedDRA and WHO Drug, ensuring that adverse events, medical history, and medications are consistently and accurately coded for regulatory submissions. 🧾
04Data Lock and Database Closure
We manage the database lock process at the end of the clinical trial, ensuring that all data has been reviewed, cleaned, and finalized. Once the database is locked, we prepare the data for statistical analysis and regulatory submission. 🔒
05Regulatory Submission Support
Our clinical data management services are aligned with the requirements of regulatory agencies like the FDA and EMA. We prepare the necessary documentation and ensure that your clinical trial data is ready for submission, including support for CDISC standards such as SDTM and ADaM. 📝
06Why Choose Us?
Trusted IT Solution & Service Business Company
Expertise
Our team consists of skilled developers with extensive experience
Quality Assurance
Our Aim is to quality means we conduct thorough testing
Custom Solutions
We understand that every business is unique.