Recruiting Subjects
First and foremost, we are here to establish a working relationship between clinical trial sponsors and potential local Principal Investigators. We work with participating physicians to screen every potentially eligible subject in their electronic medical records (EMR). There are many EMR software options, and we have experience most, if not all. We can help provide estimates of how many potentially eligible subjects are in a given area and provide insight into recruitment strategy.
Dashboards and Custom Reports
Identifying measurable benchmarks is vital to the success of any initiative. We can help your organization define and track benchmarks and other data points with interactive dashboards. Using either the data in your clinical trials management system or a custom database build, we can track useful data related to our study sites or the entire protocol. Custom reports can be developed to track multiple related data sources or format data for export to the key shareholders. If you can imagine a report, we can bring it to life.
Regulatory Management
There is no substitute for experience when it comes to maintaining regulatory binders. Our nuanced understanding of regulatory procedures will ensure standardized submission formatting and prompt turnarounds. We are capable of providing the technical infrastructure necessary to capture all of a study’s regulatory documentation and corresponding electronic signatures as well as manage user access. We can manage local binders or all binders for a given study.
Site Initiation Preparation
Study sites vary widely in their experience with research. In our experience, sites are not always aware of their responsibilities or capable of executing study procedures. We go over our tried-and-true study site initiation checklist with the local Principal Investigator as well as all potential research staff. We guarantee that any site we prepare will be ready to hit the ground running.
Protocol Monitoring
Study procedure compliance is one of the hardest aspects of a study to control, especially in a remote setting. Our research applications are capable of tracking deviations, safety events and logging audit findings. Our clinical experience has taught us what common deviations to look for. Once a pattern of deviations develop, we can prepare educational resources for research staff to quell the trend. We offer both remote and local monitoring services to ensure the protocol runs as smoothly as possible.
Research Billing
The world of research billing is ever increasing in complexity. We can provide coverage analysis services as well as provide infrastructure to generate invoices, track collections and organize local documentation. We can negotiate with local sites on behalf of your organization or standardize the billing for an entire protocol. Each institution’s research billing pipeline has their own set of needs; we are flexible enough to tailor custom solutions or provide additional bandwidth to existing work flows.