project management

ClinDatrix ensures that it delivers quality CRO services to its clients through close clinical project management techniques and well-honed tracking and reporting systems. At the helm of each of our projects is a capable project manager, reporting to Laurie Mellott.

ClinDatrix appoints a clinical project manager to be the team leader for each clinical study. The clinical project manager leads the team of professionals that may include CRAs (clinical research associates), data managers, programmers, biostatisticians, medical writers and regulatory associates. Teams can be made up of staff members, contractors and/or consultants from either ClinDatrix or the study sponsor. The clinical project manager also promotes interaction, clarifies team member responsibilities and ensures accountability by individual team members as well as by the project team as a whole. The following are key project management tasks that we offer to our clients.

Planning and Tracking

We work with our clients to thoroughly understand the study objectives, parameters and protocol. From that understanding, we establish and maintain study milestones throughout the course of a clinical investigation. Our clinical project manager is responsible for developing the project management plan, clinical monitoring and communications plan and study timelines. Our clinical project manager also oversees the development of the trial master file for each study and is responsible for ensuring that all of the team members, including those representing the sponsor, are kept abreast of study progress.

Protocol Design

ClinDatrix designs and generates study protocols based on client input and best practices. The process involves multiple stages of review and relies on the expertise of our clinical, data management and biostatistics teams. A protocol timeline is developed and closely adhered to so that our clients are aware of every step of the process, from protocol synopsis to final protocol approval.

Site Identification and/or Contract Management

ClinDatrix helps our clients identify, recruit and initiate clinical sites that are particularly well suited for the individual studies. We develop a thorough site feasibility questionnaire as part of the site identification and qualification process. An analysis of the completed questionnaire is performed by the clinical project manager and the results are reviewed with the client to facilitate the selection of the sites. We also provide contract management to the selected sites wherein we track, oversee and execute contracts and administer grant payments to the clinical sites.

Interaction with IRBs

ClinDatrix works with our clients to ensure that their protocols are ready for IRB review. We also interface with local and central IRBs to ensure that the IRB submissions are reviewed in a timely fashion.

Outsourcing Management

ClinDatrix oversees and manages central laboratories, local laboratories, interactive response technology (IRT) vendors, imaging services, clinical adjudication committees, data safety monitoring boards and independent consultants.

Monitoring Strategy Development

For each study, ClinDatrix develops a clinical monitoring plan that includes a customized monitoring strategy for the clinical trial. The plan stipulates the number of monitors required, the scheduling and frequency of monitoring visits and the duration of the clinical site visits. We offer the greatest value to our clients by assigning CRAs who have relevant therapeutic experience and who are located within close proximity to the clinical study sites. Our CRAs are senior, and all have more than five years of monitoring experience.

CRF/eCRF Completion Guidelines

Relying on the expertise of our data management, clinical and medical safety staffs, ClinDatrix develops instructions for completing CRFs/eCRFs so that they conform to the protocol, satisfy the trial data needs and ensure subject safety. Most importantly, the instructions are written clearly so that site staff CRF/eCRF completion activities are consistent across each trial’s clinical sites.

Clinical Trial Materials Management

ClinDatrix ensures that all of the clinical sites in each trial are supplied with and instructed in the use of the informed consent forms, CRF/eCRF instructions, study guidelines and other clinical trial materials. In many studies, we also provide periodic newsletters to keep the clinical site staff informed of the trial progress and any clarifications in the study processes.

Efficient Data Flow

Working in conjunction with our clients, ClinDatrix implements an efficient data flow system that integrates CRF and query flow among the clinical sites, CRAs, sponsor, project management and data management.

Key Personnel Training

ClinDatrix trains key clinical site staff utilizing investigator meetings and on-site personalized training as well as office-based teleconferences and webinars. Collaboratively with our clients, ClinDatrix develops protocol specific training for the project team assigned to the clinical trial. This training includes the background scientific history for the conduct of the clinical trial, a focus session on the therapeutic indication, specific protocol requirements and a detailed review of the completion of the CRFs/eCRFs. Practice and hands-on sessions reinforce the training presentations. In addition, ClinDatrix uses its proprietary electronic training system, TrainDatrix, for training in the Oracle Clinical Remote Data Capture (RDC) Onsite system. TrainDatrix can be accessed via the web by clinical site personnel, clinical monitors and sponsors for their convenience.

Patient Recruitment

The ClinDatrix project management plan for each study includes measures for ensuring that patient recruitment and enrollment rates keep pace with the trial timelines. ClinDatrix advises sponsors on clinical protocol design that selects the appropriate patient population while not restricting the eligible subject pool too severely. Ongoing site management activities include steps to keep the clinical site staff as well as the enrolled subjects engaged in the trial. And continuous monitoring of the enrollment rates enables ClinDatrix to address potential challenges before trial delays occur.

Trip Report Review and Submission

The clinical project manager reviews the monitoring trip reports prepared by the CRAs. Final trip reports are collected, reviewed and submitted to the client by the clinical project manager.

Quality Assurance

ClinDatrix ensures quality monitoring performance by “monitoring the monitor.” CRAs are monitored to ensure adherence to SOPs (client’s or those of ClinDatrix) and to protocol specific procedures. Sponsors also are invited to co-monitor with our CRAs as per their preference or quality assurance practices.

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