COD Research’s Clinical Project Management
Clinical project management entails coordinating all aspects of a clinical trial that significantly impact the research time and cost to develop a drug or device. It is an indispensable part of keeping all the activities on track by the efficient project manager.COD Research's Project Manager:
● Obliges as a chief resource and point of communication for the sponsor and project team.
● Delivers leadership and direction to the project team, comprising stipulations for time, quality, and cost of deliverables
● Utilizes global proficiencies, systems and processes to assure efficiency and accuracy throughout the project.
● Management framework to elevate the skills of functional leads and determination.
● Focus on the quality and efficiency of individual tasks.
● Follows risk management process, addressing potential complications to project delivery.
● Maintains a flexible, can-do approach to address issues innovatively and proactively.
Project Planning & Execution
Planning, organizing, and effective management facilitate transparency and controlling resources to achieve study goals. Detecting foreseeable problems/issues via monitoring the project’s critical path supported and optimized to perform all the project progress keeps things focused and moving forward at the highest possible level every day, thanks to dedicated expert Clinical Project Managers (CPMs).
Risk Management
Risk management is not only about avoiding or mitigating claims; it is a tool for improving quality in each possible step of clinical development.
Demarcating risk assessment frequency, cross-functional team involvement, risk scoring based on impact and likelihood, proactive measures to decrease/eliminate the risk at impact or frequency level, pre-defined action plan if the risk becomes an issue, and most importantly, we ensure proper execution of the strategies.
● Risk Management Planning
● Risk Identification (General and study or product-specific)
○ Categories
○ Select
○ Implement
● Risk Assessment
● Risk Control and Response Plan (Monitoring, Avoiding/alternating approach, Securing, Mitigation, and minimization)
● Risk communication and review
● Risk sharing, learning, and training.
Vendor Management
The study team takes more than just objects to conduct a clinical trial. The best-fit approach of COD Research brings the qualified vendors to the right place at the right time to support seamless trial execution.
We have both strategic and tactical levels of outsourcing activities based on the project requirement.
● Defining Requirements Specifications & vendor selection criteria
● Vendor Identification
● Vendor Evaluation/Auditing
● Vendor Negotiation and Selection
Resource Management
One of the bottlenecks in CRO is resource management; availability and access to adequate resources promptly and at an appropriate location is the golden motto of our resource management team. A clinical trial is an ocean full of multi-tasking, cross-functional involvement activities, and day-to-day-dynamic challenges; seamless working of all these domains requires a proficient workforce, vendors, and effective asset allocation.
The factors that critically lead to effective resource allocation.
● Work Breakdown Structure (WBS) for each project.
● Appropriate project-specific training for the individuals involved.
● Timely availability of required assets (including but not limited to Materials, Devices, Investigational interventions, ancillary supplies, etc.)
Conceptual Phase
Protocol Synopsis
Scheduling of Activities
Planning
Protocol
Clinical Model
Site Selection
MOP
Case Report Form
Clinical Trial Approval
Contracts with Third Party
Database Building
Drug Labeling
Implementation
Subject Enrolment
Drug Distribution
Answering Protocols
Attending Incident Calls
SAEs
Dosage Adjustments
Premature Withdrawal
Drug Disclosure
Date Query Process
Database Closure
Analysis Publication
Conducting Analysis
Submitting Abstract
Submitting Manuscript
Submitting CTR
Post-HOC Analysis
Different models
to meet diverse needs
to meet diverse needs
Insights &
Resources
Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
