About Us
Why Choose Us
Here at Ology, we focus on tailored services that best meet the needs of your company. Rather you are just getting started or the end of your clinical trial is on the horizon and you need additional resources, we are here to help push your team to the finish line.
How We Help
In addition to providing clinical study planning and design, we listen to our client's needs to see where we partner together and be a fresh pair of eyes to a problem to provide alternative solutions.
Experience the Difference
We go beyond the bar when it comes to ensuring satisfaction as you are more than just a customer to us. We ensure that you are provided with the best quality clinical team that is current with the latest global regulations.
Our Services
Study Start-Up
Contracts Management o Clinical Trial Management System (CTMS) Vendor Management o IRB Submissions o ICF Development o Investigator Brochure Development o Investigational Product Training o TMF Build and Maintenance
Project Management
Project Management Plan Development o Scope of work and timeline expectations o Reports of study progress o Budget review and analysis o Validation, tracking and reconciliation of investigator payments o Coordination and management of vendor subcontracting
Site Monitoring
Initiation Visit Material Development o Clinical Monitoring Plan Development o Source Data Worksheet Development o On-Site Visits o Remote Data Monitoring o Device Accountability
Safety and Medical Monitoring
Safety Monitoring Plan Development o Adverse Event Review o Data Safety Monitoring Committee Management
Data Management
Data Management Plan Development o Electronic Database Vendor Management o Case Report Form (CRF) design o Database design o Data management plans/guidelines o Data validation and review
Medical Writing
Clinical Study Reports o Investigator brochures and annual updates o Regulatory applications: IND, NDA, BLA, IDE, PMA o Study manuals o Study protocols