Our clinical trial project management is founded on 25+ years of expertise in the industry. Get the necessary information, data, and documentation to maximize the success of regulatory submissions and advance from pre-clinical to approval.
Lean on expert support for global trials. We coordinate single and multi-site studies, maintain compliance with international regulations, and implement unique solutions to meet your data requirements, study timelines, and budgets.
Our dedicated project managers operate under full transparency, providing clear updates every step of the way.
Detailed reports are prepared after each site visit with regular updates and reporting on site performance and compliance.
Maintaining the Trial Master File (TMF), preparation and submission of necessary regulatory documents to ensure compliance with IRB and other regulatory requirements.
Ongoing reports and data extracted from the EDC system detail clinical data collected and study findings.
A comprehensive summary of all aspects of the trial, including methodology, results, and conclusions.
IRB documentation review and revision
IRB fee facilitation
Handling of IRB / IEC / MOH submissions
Controlling study management costs
Contract negotiation with investigator/site
Contract administration
Translation of patient-facing materials
Preparation of training materials for site staff
Preparation of collection kits
Shipment of study materials and supplies
IP and inventory management
Weekly update meetings
Regulatory file preparation
Site regulatory document verification
Compliance oversight
TMF maintenance
Electronic Data Capture (EDC)
Study development and configuration
Electronic Case Report Form (eCRF) design
eCRF validation
Study testing and validation
EDC user setup for site staff
Importation of study-specific IDs
EDC user training prep and conduct
Data extraction
Preparation of sponsor data file
EDC system administration
Preparation of monitoring plan
Pre-study qualification visit
Site initiation visit
Interim monitoring visits
Monitoring report draft and review
Ongoing remote monitoring
Closeout visit
We partner with your scientists who are passionate about developing solutions that improve patients' lives. With Boca Bio, your team gets the necessary cancer specimens, services, and data to develop therapies, companion diagnostics, biologics, and novel cell and gene therapies. Let us support the development of your next precision oncology breakthrough.
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Boca Bio offers a complement of clinical research services, including site and collection management, data capture, and coordination to ensure your pre-clinical and discovery studies run seamlessly to achieve desired milestones. We offer end-to-end services, so you don’t have to manage the details.
Yes, Boca Bio maintains compliance with all IRB approvals in place for our U.S. sites, as well as ethics committee/MOH approval for all international sites.
One of the advantages of using Boca Bio is that we have established IRB/ethics committee/MOH approvals in place for your projects. Some IRB/ethics committee/MOH approval processes can take weeks or months, depending on the site and location. If a protocol approval is not in place, then an application will be submitted to the IRB/ethics committee/MOH.
We have a global footprint of 120+ collection sites worldwide, in over 60 countries.
Yes, we can provide monitoring services for your research study. We conduct a site initiation visit, interim monitoring visits, and a project close-out visit.
Yes. From initial concept to market approval or study closure, our team ensures comprehensive project and site management throughout every phase of your project.
Our site and project management approach combines meticulous planning, continuous monitoring, and effective communication, ensuring projects stay on track and within budget.
