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FAQs

General Questions

Profondex specializes in clinical data management, providing comprehensive solutions for clinical trials, including data collection, cleaning, validation, and analysis to ensure regulatory compliance and high-quality outcomes.

Our clients include pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and academic institutions conducting clinical trials.

Clinical data management (CDM) involves the collection, processing, and analysis of clinical trial data to ensure accuracy, consistency, and compliance with regulatory standards like FDA, EMA, and ICH guidelines.

We use robust data management systems, automated validation checks, and a team of experienced professionals to ensure data accuracy, consistency, and integrity at every stage.

Services

  • Study design and database setup
  • Electronic data capture (EDC) solutions
  • Data validation and cleaning
  • Statistical analysis and reporting
  • Regulatory submission preparation
  • Risk-based monitoring

Yes, we provide state-of-the-art EDC systems that allow secure, real-time data collection and monitoring for clinical trials.

Absolutely. Our processes are aligned with global regulatory standards, including FDA 21 CFR Part 11, GDPR, and ICH guidelines, ensuring seamless compliance.

Yes, we tailor our services to meet the specific needs of each trial, ensuring flexibility and precision in managing clinical data.

Security and Data Privacy

We employ advanced encryption, multi-factor authentication, and secure data hosting to protect sensitive clinical data. Additionally, our systems undergo regular security audits and comply with industry-leading standards.

Yes, Profondex fully complies with GDPR and other relevant data privacy regulations, ensuring that all personal and sensitive information is handled with care and transparency.

Your data is securely stored in our state-of-the-art data centers located in compliance with regional and global regulatory requirements.

Technology

We leverage industry-leading software for electronic data capture (EDC), clinical trial management systems (CTMS), and statistical analysis tools to deliver seamless and accurate data management solutions.

Yes, our systems are designed to integrate with most industry-standard tools, enabling smooth data transfer and centralized management.

Process and Support

The timeline depends on the complexity of the study, but we typically complete database setup and testing within 4–8 weeks.

We provide end-to-end support, including real-time monitoring, troubleshooting, and regular updates to ensure the smooth conduct of the trial.

After the trial, we provide final data analysis and reporting. Data is securely archived and retained per regulatory requirements, ensuring it remains accessible for audits or future studies.

Cost and Engagement

Our pricing is flexible and tailored based on the scope and duration of the project. Contact us for a customized quote.

Reach out to us through our website’s contact form or email, and our team will guide you through the onboarding process.

Miscellaneous

Yes, we provide comprehensive training for site staff and investigators to ensure seamless adoption of our EDC systems.

Yes, we have the capability and experience to manage multi-center, global clinical trials, ensuring compliance with regional regulations and streamlined data handling.

Yes, we provide medical coding services using industry-standard dictionaries like MedDRA and WHO Drug.