Overview of Bioglobal Clinical Research
At BGCR we are dedicated to making certain your studies proceed smoothly, on schedule, and in compliance with regulatory standards. With a global vision, we provide a range of expertise-based consulting Clinical Research Services for Sponsors of Phase I and Phase II global Clinical Trials.
What makes us DIFFERENT
Partnership
Our scalable and flexible solutions are uniquely designed for each client and clinical program individually.
We take pride in our “hands on” approach and enjoy not just working with our clients but partnering with them.
Industry Experience
We understand what it takes to bring a drug candidate into the clinic. Our transformative clinical operations leaders provide industry track record experience and are dedicated to making certain your studies proceed smoothly, and on schedule.
Extraordinary Service
Under our direction, you can be confident your study is conducted in strict compliance with the protocol, Standard Operating Procedures, and current regulatory requirements.
Our Services
Contact Manager
We offer a seamless path of communication with external third party vendors, cross-functional teams, and stakeholders.
Project Management
Coordinate and manage all aspects of your clinical trials, from study start-up through close-out, and day-to-day operational management, including project tracking and internal reporting.
Study Design and Protocol Development
We understand what it takes to start and grow a successful study from the ground up. Study design, protocol, informed consent form, and CRF development.
CRO Management
Whether contract negotiations have started or CRO onboarding is needed, we provide management consultation to ensure the services rendered and your organization is functioning at maximun efficiency.
Site Qualification
We will identify sites that have the capabilities your program requires to ensure requirements are met for both performance and timing. Because we have worked with hundreds of sites, we know what to look for before committing your project to a facility.
Site Management
Our services include contract and budget negotiation, clinical site selection and setup, with an emphasis in shortening site activation timelines. Our services also include support with central IRB or local IRB/EC submissions.
SOPs and Operational Plans
We assist in the development/updating of SOPs and Clinical Operational Plans for Phase I and II clinical trials to ensure FDA expectations for process control are met. We also evaluate existing SOPs for content, consistency, and compliance.
GCP and Staff Training
Developing the technical skills and expertise of staff is a time consuming effort and can prevent managers and supervisors from their primary tasks. We provide both general and customized training programs to meet the needs of your staff and organization.
Monitoring Oversight
Oversight of in-house monitoring activities and CRAs, facilitating issue resolution with the CRO study team, Our services offer comprehensive oversight of CRO monitoring and sponsor sign-off on field reports.
Risk Management
Forecasting potential risks is a key element to ensure the smooth conduct of your clinical trial. We provide comprehensive risk management, and risk mitigation through oversight of third party vendors and sites assessment.
CTMS Implementation
Implementation oversight of the clinical trial management system and Trial Master FIle tailored to your specific trial. The services provided are geared to help our clients maintain the highest standards in regulatory compliance and achieve healthy regulatory compliance with ease.
Enrollment Optimization
We offer extensive experience in strategic implementation of recruitment materials that boost enrollment to achieve enrollment goals quickly and less costly than traditional methods on clinical trial recruiting.
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Upcoming: June 25, 2023
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