The success of project lies in the efficient project management.
We manage your project, like you would, with utmost diligence and responsibility. Timelines, cost, and quality are just as important when you outsource a study as when you manage it in-house We consider pro activity to be fundamental because proactive project management can identify risks and mitigate losses by timely resolution of issues. Hence, we have created a process that provides commitment and accountability.
CBCC-Vibgyor offers therapeutically aligned professionals with Industry, CRO and site experience. Our project managers understand the site dynamics as well as sponsor demands for a trial enabling them to work effortlessly on project management aspects such as recruitment, compliance, data quality, risk mitigation and most importantly timeline and budget management.
Overall project oversight of day to day activities, CRA oversight, proactive communication with the sponsors, team members and vendors, tracking trial metrics, budget and timeline are the functions of the project management. For a client who has worked with us, we try to provide the project team that worked in the earlier study, in order to curtail the learning curve of the sponsor processes and modus operandi.
Our Clinical Trial Management Service includes following:
- Project Plan development
- Study set-up and site start up
- CRA resourcing, mentoring, co-monitoring support
- Third party vendor management
- Ensuring subject safety and regulatory compliance
- Managing study supplies
- Managing Sponsor communications
- Ensuring that the trial team performance is compliant with all applicable regulatory requirements, project-specific SOPs, and industry best practices
- Managing client expectations for on-time and on-budget performance
CBCC-Vibgyor has established long standing working relationships with a large network of experienced, qualified, and skilled investigators and high-performing sites spanning multiple therapeutic areas across the country for drug and device trials.
We engage in a proactive dialogue with the sites prior to selection for a particular study to ensure that the site has required proficiency and resources, including the patient population. A detailed feasibility is carried out to compile the following information.
- Type of clinical setting with information regarding standard of care
- Availability of infrastructure and support team for trial related activities
- An evaluation of the patient pool, experience in past with the same study indication
- Subject identification, recruitment and retention strategies
- Study challenges with regards to protocol requirements, patient participation and local regulatory perspective
- Assess investigator interest, competing studies
The feasibility is also an opportunity to learn the challenges for study conduct and patient enrollments. The investigator feedback is conveyed to the sponsor and every attempt is made to screen the best suitable Investigator. This initial engagement with the sites, builds a strong positive relationship with the investigator and investigative sites, which helps in seamless execution of the study.
If the sponsor requires swift expansion of the study, additional sites are quickly set up with a detailed feasibility and on site visit by our team.
Site training and coordination
A site specific CRA, is a primary contact for communication with the sites during all stages of the study.
An in-depth training is a must to establish a base for quality conduct and is a route to obtain high quality data. Site initiation visit, conducted with practical approach, provides clear direction for execution of study. Our Project Managers and CRAs are experienced in delivering on site training.
Our processes integrate between operations teams for speedy site initiation and activation for enrollments. Our experienced CRA team oversees the conduct of the study ensuring compliance to the protocol, study drug/device use, applicable regulatory requirements and ICH GCP. CRAs proactively communicate with the site staff to follow on the enrollments, to understand challenges at site and effectively trouble shoot. They also oversee the clinical supplies at site including the study drug supply.
Effective Clinical Monitoring forms the backbone for the efficient execution of a Clinical Trial. We firmly believe that robust clinical monitoring is vital to a clinical trial to yield valid regulatory acceptable clinical data.
Though our CRAs are assigned on their therapeutic experience, they receive study specific training by our therapeutic experts, ensuring that they remain updated about the current clinical practices and basics of therapeutic segment. Mastering the protocol requirements is must in order to address site queries. CRAs receive comprehensive and continued on-the-job training through our internal training and development program that helps them develop a sound understanding of each protocol, standard operating procedures (SOPs), and gain a thorough knowledge of ICH-GCP and all applicable regulatory guidelines.
CRAs are allocated to an average of only 2 studies at a time, which enable them to follow the process meticulously, attend to the site queries patiently, iron out the minutest of issues effectively, surpassing compliance at all levels.
Our CRAs understand the importance of effective and timely communication internally within the team, with study sites and sponsors. Our flat organizational structure enables quick and clear communication for the entire team and ensures appropriate actions to tackle the challenging situations.
Our services include:
- Investigator Identification and Site selection
- Site Qualification Visits
- Planning and executing Investigator Meetings
- Site Initiation Visits and Site staff Training
- Informed Consent Form review
- Interim and Routine Monitoring Visits
- Source data verification and CRF data review
- Monitoring Adverse Event reporting
- Performing drug and/or device accountability.
- Ensuring regulatory compliance
- Close Out /Study Termination Visits
A Risk-Based Monitoring Model
Since US FDA encourages greater reliance on centralized monitoring practices than has been the case historically, with correspondingly less emphasis on on-site monitoring, we can capitalize on the technology. With the proper systems in place, risk-based monitoring is an effective way to meet the growing challenges to ensure proper execution of study protocol and deriving valid study results in a cost effective manner.
Incorporating Centralized monitoring activity offers real time overview of data, with early risk detection and mitigation advantage. This real time monitoring improves efficiency of CRAs and focus can be adjusted to the issues and sites where needed most, avoiding disturbance to competent and well performing sites. Centralized monitoring offers an advantage of reduced on site monitoring visits and at the same time since the data is reviewed on real time basis CRA remains well informed, well prepared and can efficiently plan on site visit, if needed.