Clinical Trial Operations
Clinical Trial Operations
Regulatory demands require a well thought out, conscientious clinical trial design. Our motivated team of clinical research experts can deliver this to you. As a full service CRO, we understand your program requires detailed planning, oversight, monitoring, and execution, ensuring costs are managed and timelines are met.
Trial Designs
Thorough planning, by our forward-thinking team of experts is invaluable to keeping your program running at the highest regulatory, ethical, and clinical levels.
Working Together
We believe that early collaboration saves money, hassles, headaches and time. We support clients as early as possible, helping with GMP planning and compliance.
Powerful Results
Our experienced statisticians deliver accurate results and understand what is required and can often reduce costs, regulatory complications, and frustrations.
Planning Your Trial
Planning by a team of professional statisticians, regulatory specialists, and medical experts is invaluable.
We support our clients early in planning scientific objectives, trial outcomes, protocol creation, trial conduct, and regulatory compliance.
Our statisticians will assist with statistical analysis and cost reduction.
Our regulatory review team will assess your marketing campaigns from a legal, regulatory, and medical perspective.
- Early Collaboration & Guidance
- Detailed Trial Planning
- Cost & Time Management
- Statistical Planning
- GCP Planning & Compliance
- Regulatory Planning & Consulting
- Target Product Profile Assistance
- IND Submission
During Enrollment
Our Trial Management Team is knowledgeable, responsive, and committed to your trials success.
After trial design and site allocation, frequent communication is paramount.
We will monitor the study continuously, focus on enrollment, proper documentation, GCP requirements, and work to ensure personnel respect and adhere to timeline targets.
- Strong Communication
- Reliable Collaboration
- Onsite/Remote Qualification
- Site Personnel & PI Training
- Protocol Training/Adherence
- Onsite/Remote Monitoring
- Query Resolution
- Trial Master File Management
After Enrollment
We understand that “Data is King” and will ensure your clinical trial results are clear, cost effective, and on time!
Regulatory submissions determine a clinical trial’s success or failure, starting with filing the IND all the way to the NDA submission. We understand what the FDA needs to see and how to present the data.
Your data is safe with us. We can securely store all electronic and paper records throughout the trial and then safely transfer them to whomever you require.
- Clinical Site Closeout Visits
- Clear Clinical Trial Results
- Regulatory Submissions
- NDA Submission
- FDA Communication
- Audit Assistance
- Statistics & Data Management
- Secure Document Transfer
Want to know more? Let's Talk!
Are you looking to start a clinical trial? Do you need trial management or regulatory help? We have you covered!