Clinical Research Management ( Drugs and Medical Device), and Regulatory submission.

 

Our most frequent roles and responsibilities:

We assists with the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical research studies. . 

We develop or utilize project management tools, delegating tasks, driving timelines, to support Sponsors and ensure milestones are met on multiple projects or studies.

We review, revise, train sites on study protocol, SOPs, and guidance documents, to ensures staff are properly trained and are utilizing the most recently approved processes.

We leads study start-up, team meetings, and ongoing protocol trainings.

We participate in study feasibility, pre-site visits, site initiation visits, monitoring visits, audits, and close-out visits.

We assist in the development, or maintenance of study specific case report forms, source document tools, trackers, and templates to be used by research staff

We conducts QA and QC reviews of participant charts, and regulatory files to ensure adherence to protocol, GCP guidelines, and SOPs.

We prepare, or submit regulatory packets, maintain essential documents, stay on top of deadlines for continuing reviews, and prioritizing protocol amendments or modification.

We show vigilance in patient safety, protocol compliance, and data integrity.

We adhere to  regulation and guidelines.
Our clinical trial planning process can help you design a clinical study focused on your product’s specific needs, gather data efficiently while maintaining all regulatory requirements.

We assist our clients with designing a comprehensive clinical study plan that can be used to support regulatory submission, estimate project timelines and costs;
We develop the necessary study conduct materials (e.g., clinical trial protocol); and  request accurate and detailed proposals for study start up and execution.

Our approach to managing clinical trials projects is always effective because we utilized   our industry and educational experience with effective project management tools and resources that helps move the trials along without any unanticipated delays.

We managed all trials using effective risk management tools.

 We help our clients  develop strategies  from product development to final marketing approval, post-approval phase, and quality system improvement and remediation.

Using our extensive industry experience with conducting clinical trials, we can help you design and complete studies that collect the right data, in a cost-effective way. 

Responsible for onsite and remote PSSV, SIV, IMV, Pre-audit, Booster visit and COV.
Perform RBM monitoring as per monitoring plan.
Performed PSSV, tour and verify responses to Feasibility questionnaire, access site readiness and write visit report.
Maintain a thorough understanding of study protocol and protocol amendments for assigned projects etc.
Performed SIV: Protocol training, ensure enrollment preparedness, provide study tools, confirm SOP for SAE reporting etc.
SIV: Explain data entry timeline, eCRF completion, review regulatory requirements, review EC / IC, review ALCOA-C etc.
Monitor and audit selected sites within the project as the assigned CRA.
IMV: Review outstanding items, SDV, SDR, review regulatory binder, IP accountability, training logs, protocol deviation etc.
Tasked with maintaining the day-to-day oversight and managing assigned projects.
Tasked with managing other CRA site assignment, to best support project needs.
Tasked with creating and maintaining TMF.
Assist with the development of protocols and monitoring plan.
Plan and execute a monitoring plan for assigned CRA’s with SSV, SIV, IMV and COV.
Tasked with sponsor budgeting for sites and negotiating.
Access the quality and integrity of site practices in accordance FDA, and ICH (GCP) guideline.
Tasked with resolving issues or escalating issues that come up during the course of a clinical study.
Track with assisting with activities such as regulatory submissions, recruitment, CRF completion etc.
Guide sites with IRB submission and renewal process and ensure site compliance with IRB requirements.
Train team on metrics including recruitment, site visits, data quality, patient safety, timely submission of trip visit reports etc.
Customize, and annotate PSV, SIV, IMV, and Closeout (COV) Report, Confirmation Letter (CL), and Follow-Up-Letter.

 

Provide regulatory leadership on project team(s), collaborating with senior leaders and cross-functional team members on development and implementation of regulatory strategies to expedite the development of investigational products.

We are consistent with overall program goals and regulatory requirements; anticipate and mitigate strategic risks.

We execute regulatory strategies and perform data assessments to enable timely and effective preparation, review, and submission of key regulatory filings.

Responsible for regulatory submissions, including original INDs/BLAs, amendments, meeting requests and briefing documents, responses to FDA requests, and maintenance submissions, in collaboration with Regulatory Portfolio Management.

 We have the  ability to manage all aspects of regulatory activities from pre-IND through late-stage clinical development; product registration/commercial experience

We have demonstrated hands-on experience leading preparation, submission, and maintenance of key regulatory filings, in collaboration with project teams and health authority meetings etc.