Profile
Clinical Data provides a cloud-based platform to standardize and monitor clinical trial data, ensuring compliance with FDA regulations and reducing costs.
Clinical Data Inc. is a healthcare technology company focused on reducing the cost and risk of clinical trials through regulatory-compliant data standardization and risk monitoring. The company addresses key challenges in clinical trials, which typically span 10-12 years and cost over $1 billion, with a success rate of just 1%. Clinical Data's platform aims to streamline the process by ensuring compliance with CDISC data standards, which the FDA mandates for all pre-clinical and clinical data submissions.
The company also promotes a risk-based monitoring approach to cut site monitoring costs by 25%. Despite the critical need for such solutions, the market lacks affordable, integrated technology platforms that meet these requirements. Clinical Data's offerings are designed to provide real-time consolidated views of study data across CROs and investigative sites, submission-ready datasets, and analytics to eliminate data-related FDA rejections. The company operates in a high-stakes environment where 50% of NDAs are rejected due to clinical data issues, positioning its solutions as essential for biopharma and medical device companies.
Who buys this
- Biopharmaceutical companies conducting clinical trials
- Medical device manufacturers requiring FDA submissions
- Contract research organizations (CROs) managing trial data
- Regulatory agencies reviewing clinical trial submissions
- Academic institutions involved in clinical research
Strengths and what to watch
Strengths
- Compliance with FDA-mandated CDISC data standards, reducing rejection risks
- Real-time data consolidation across multiple sites and CROs, enhancing oversight
- Risk-based monitoring approach that cuts site monitoring costs by 25%
Watch for
- High competition from established clinical trial management systems
- Dependence on FDA regulatory mandates for adoption
- Potential resistance from CROs accustomed to legacy systems
Key Information
- Founded
- 1969
- Headquarters
- North Wales, Pennsylvania, United
Frequently Asked Questions
What is clinical data management?
Clinical data management involves standardizing and monitoring clinical trial data to ensure compliance with regulatory standards like FDA mandates. It aims to streamline trials, reduce costs, and minimize risks associated with data errors or non-compliance.
How does Clinical Data Inc. reduce clinical trial costs?
Clinical Data Inc. reduces costs by implementing a risk-based monitoring approach, cutting site monitoring expenses by 25%. Their platform ensures compliance with CDISC standards, minimizing FDA rejection risks and streamlining data submission processes.
What are CDISC data standards?
CDISC data standards are guidelines mandated by the FDA for organizing clinical trial data. They ensure consistency and compliance in data submissions, reducing rejection risks and improving the efficiency of clinical trials.
Why is FDA compliance important in clinical trials?
FDA compliance ensures clinical trial data meets regulatory standards, reducing rejection risks. Non-compliance can lead to costly delays or trial failures, with 50% of NDAs rejected due to clinical data issues.
What is risk-based monitoring in clinical trials?
Risk-based monitoring focuses resources on high-risk areas in clinical trials, reducing unnecessary site visits and costs. This approach improves oversight and efficiency, cutting site monitoring expenses by up to 25%.
Who uses Clinical Data Inc.'s platform?
Clinical Data Inc.'s platform is used by biopharmaceutical companies, medical device manufacturers, contract research organizations (CROs), regulatory agencies, and academic institutions involved in clinical research to ensure compliance and streamline trial processes.
Sources
- www.clindatainc.com — Company's focus on reducing clinical trial costs and risks
- aspe.hhs.gov — High site monitoring costs in clinical trials
- www.manhattan-institute.org — 50% NDA rejection rate due to clinical data issues
- www.ncbi.nlm.nih.gov — Challenges with old legacy technologies in clinical trials