How Does A Full-Service Medical Device CRO Support Your Clinical Trial?

Clinical Planning

The planning stage sets expectations for how your team will work together.

First, you need a regulatory strategy that aligns compliance activities with your business objectives. Next, you'll need to establish protocols that protect patients without making the trial overly restrictive.  Finally, you'll want to establish a risk-based monitoring plan that takes into account your trial's unique characteristics. 

See how our FAIR Shake™ method helps you ensure compliance from the start.

Study Logistics

Your team may need help with site selection, initiation, or patient enrollment before getting started. 

Once your sites are up and running, you may also experience delays due to staff shortages or gaps in your process. 

Our team can assist with all the logistics needed to begin your trial and support your research coordinators as you go. That includes assisting with data entry and resolving discrepancies. 

Implementation & Training

The cost of implementing, conducting and monitoring a large clinical research trial can cost as much as $1 million per site, according to the National Center For Biotechnology Information. Failing to follow the protocol at the site level can invalidate data, potentially resulting in hundreds of thousands of dollars in wasted resources. That's not counting the revenue lost from delays.

Having a properly trained staff is your best defense against compliance issues that can derail your trial. 

We can support your team with customized training online or in person. 

Monitoring

You already know monitoring is a critical part of protecting patients, ensuring compliance and maintaining data integrity in clinical research. 

What you may not know is where to find well-trained monitors. Although the Code of Federal Regulations states monitors should be qualified by training and experience, it does not require any formal training. Additionally, high turnover is common in the monitoring industry because of high expectations and a steep learning curve that often outpaces a monitor’s pay. 

Working with a contract research organization (CRO) for monitoring can help you avoid many of the challenges related to hiring and retaining monitors. 

Auditing

Every year, the FDA releases the most common inspection findings — and every year, some common themes emerge. 

Regular audits can help you identify compliance issues before the FDA does and address them before they become bigger problems. 

We can conduct in-person or remote clinical research audits, including: 

• Site GCP audits
• Vendor qualification audits
• Sponsor/CRO audits
• Trial master file audits

We'll also train your team in best practices throughout the process.

Safety Monitoring

Every successful clinical trial must protect patients while collecting complete, accurate data that proves the safety and effectiveness of the drug or device.

To achieve this, you need to work closely with your data management team as well as safety monitoring groups like your data safety monitoring board or clinical events committee.

IMARC also offers full-service safety management. That includes recruiting qualified physicians for a DSMB or CEC, communicating with members, and documenting meetings. 

Data Management

Like Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP) are based on regulations and guidance. Specifically, clinical research sponsors, principal investigators, and others can refer to the guidelines outlined by the Society for Clinical Data Management and 21CFR Part 11 regarding data management of electronic records. 

Our team follows an established process for consistent data and safety management. 

We can help you select the right electronic data capture system, build it according to your specifications and work with site monitors to ensure data is entered accurately and in a timely manner. If you have decided to use electronic patient-reported outcomes, such as questionnaires, we can help you manage that process and ensure compliance. 

We can also sort, clean and analyze your clinical trial data and assist with database locking as your trial comes to a close.