Study Management

Your approach to study management can influence the success or failure of your study and whether or not you receive approval to market your device.
Many MedTech companies – especially start-ups – don’t have the bandwidth to manage their studies internally, as it takes a significant amount of time and resources to manage a clinical study.
Outsourcing study management services through an experienced, full-service contract research organization (CRO) can help save time (reducing study start up time) and money (eliminating resource constraints and staffing burdens), while improving communication, upholding study quality, and providing you with all the information you need so you can remain focused on business operations beyond evidence generation.

Your clinical study must comply with good clinical practice (GCP) laws and regulations. Code of Federal Regulations (CFR) required for medical device trials in the US include 21 CRF 11, 11 CFR 50, 21 CFR 54, 21 CFR 56, 21 CFR 812, and 21 CFR 814.
Risk category, risk assessment, potential benefits, and risk-benefit analysis must be assessed.
Data collected from patient forms (e.g., billing forms) should not include or retain any data elements that constitute personally identifiable information (PII) under HIPAA rules, including but not limited to: name, address, date of birth, and social security number.

Serving as your Principal Investigator(s), our experts will handle site communication, establish a working rapport, coordinate an appropriate follow-up schedule, and define a site-specific data collection methodology with the appropriate points of contact at each site. We’ll take care of data collection (using site-specific data collection schedules and methodologies) and management including data tracking, de-identification, integration, security, and more.
We’ll handle all regulatory considerations, ensuring your study is following GCP guidelines and is adhering to the clinical investigation plan, with the agility to adapt if needed (unlike a traditional CRO that becomes paralyzed when challenges arise).
Acting as a true extension of your team, we’ll ensure you’re staying within your budget and are meeting your study timelines.