FGK’s Clinical Data Management

CDM is vital for clinical studies, involving the collection, management and cleaning of trial data to provide high-quality datasets for study analysis. Therefore data is being managed in the study database and quality control tools such as validation checks ensure that the data is discrepancy-free and complete.

Clinical data management not only handles high amounts of research data, but also ensures that the information collected in clinical trials is medically accurate, reliable, and compliant with regulatory standards. Key components of CDM are:

Database design and development: Designing databases tailored to specific clinical trial protocols, ensuring efficient data capture, storage and high quality of datasets.

Data governance: Establishing policies and standards for data collection, validation and cleaning.

Regulatory compliance: Ensuring all tools and data management practices are in compliance with legal and ethical standards, guidelines and regulations

At FGK, we reach these goals by cutting-edge clinical data management solutions tailored to the unique challenges of your clinical trial.

Experience the excellence of our data managers, your trusted partners in clinical data management. As the industry continues to evolve, the effective handling and utilization of clinical data become pivotal to accelerate innovation, enhance patient outcomes, and streamline regulatory processes.

… our State-of-the-art solutions

The rapidly advancing clinical research industry requires effective clinical data management tools to accelerate innovation, enhance patient outcomes, and streamline regulatory processes. Clinical research generates a wealth of data, from patient records and lab results to trial reports. The complexity and volume of this data can overwhelm traditional data management systems, hindering decision-making and slowing progress. FGK’s high-quality CDM solutions are designed to address these challenges head-on. They directly address these challenges, providing the users with information that enables smoother decision-making, faster progress, improved patient results and streamlined regulatory processes.

… our highly qualified and professional experts who think outside of the box

With a deep understanding of the pharmaceutical, biotechnology, and healthcare sectors, we are committed to facilitating your journey from data collection to actionable insights. FGK data managers record, compile and accurately pre-process your trial data. You can opt to have your data captured on paper and subsequently double-entered by our staff or electronically on site. Datasets are available in CDISC SDTM standard.

All employees in our Data Management department possess broad therapeutic expertise.

• (e)CRF design, EDC specifications and validation to minimize discrepancies
• Data cleaning and query management
• Medical coding
• Serious Adverse Event (SAE) reconciliation
• Import, reconciliation, and cleaning of all types of electronic data (lab, PK/ PD, ECG, Imaging, ePRO, etc.)
• Processing of local lab datasets
• Status/progress reports
• Management of database snapshots, interim locks and final database lock
• CDISC SDTM compliant deliverables
• Handling of rescue trials
• Support of paper-based CRF processing/hybrid trials

• Proven expertise: FGK’s experienced CDM experts use high-quality data collection tools in compliance with regulatory standards. This ensures your study data’s integrity and validity. Our team of data management experts has a track record of success in clinical research, delivering results that lead to FDA approvals and industry recognition.
• Tailored solutions: Every clinical research project is unique, and we customize our CDM solutions to align with your specific goals and requirements. With extensive experience in all important medical indications, we facilitate your journey from data collection to actionable insights.
• Advanced technology: FGK leverages the latest technological standards to stay at the forefront of CDM innovation.
• Cost-efficiency: FGK’s CDM solutions are designed to optimize resources, reducing operational costs while maximizing the value of your data.
• Comprehensive support: FGK’s high-quality support and training equips your team to make the most out of our CDM solutions

We offer eCRF solutions for sponsors, but our Data Management team can also work with any third-party EDC software on request.