Improving Quality & Efficiency through Efficient
Project Management

The Gartner Research Group (USA) reports that “Close to 30% of projects are never successfully completed, wasting about US$75 billion annually, and a startling 51% of
projects exceed their budget by 189% and deliver only 74% of expected functionality. While these data are astonishing in themselves, the greatest contributor to project failure
can be explained by one factor, namely Poor Project Management.

A project is a sequence of unique, complex and connected activities that are completed to achieve one goal or purpose in a limited timeframe. It is performed by the people and
constrained by resources. It is usually planned, executed and controlled.

A project can be thought of as “a temporary endeavour” or “an organized undertaking” and could be simple like finding a job or buying a house, to more complex like running a
campaign for political office, constructing a building, developing a new product or service, conducting a clinical study, or large like design and manufacture a car or really
huge like putting a man on the moon!

Project Management is about managing projects. It is a dynamic process and is based on accepted principles of management. It is the application of knowledge, skills, tools and techniques to meet the needs and expectations from a project. The goals of project management could be, for example, clinical (e.g. demonstrate safety and efficacy of a
drug and obtain regulatory approval) and business (e.g. finish within time and budget, and make a profit).

Often several concerns are raised about project planning including, “My work is research therefore I can’t plan it” or “How can I commit to a schedule, if I don’t know how it will
work out ” or “I don’t have time to plan –got to get it done!” However, it is important to plan a project. The Project plan is a map and a guide. If there is no map, you are most
likely to get lost. A plan helps you to understand risks and trade-offs. It is the basis for systematic plan modification and a mechanism for efficient communications.

Principles of Project Management

a. Set objectives and work towards them (e.g. achieve the project goal, keep customers happy, keep the team focus on the goal or make sure that team members work well
and everyone shares the load
b. Establish forward-looking control
c. Good decision making

Project Management processes

Various processes are linked in project management, including,
a. Initiation
b. Planning
c. Control and Executing
d. Close out

Primarily it is necessary to decide what is “Expected” from a given project, around which a project plan is built with buffer ranges. Vital signs of a project should be monitored e.g. plan change frequency, on time completion rate, or cost estimate vs. actual costs.

Estimates must be checked against the actual costs. Routine “Checkups” are arranged as early detection allows for speedy and low-cost treatment. Diagnostic tests for areas of
concern must be increased. Limits must be set for acceptable ranges. The project team may be altered when vital signs are unfavorable. A specialist may be brought in when needed!

There are core knowledge areas in Project Management including management of project integration, management of scope, time, cost, quality, human resource, communications,
risk or procurement.

The Project Plans could include plans for Resourcing, Communications, enrolment, monitoring, Site Management, Safety Management, Document Management, Quality
Management, Clinical Trial Material Management, Logistics and Medical Monitoring.
The aim of Project Management is to reduce time and cost and increase quality. Hence the three most critical success factors in any project are Speed, Quality and reduced costs
which impact on schedules, planned results and resources.

Project Time management
a. Activity definition
b. Activity sequencing
c. Activity duration estimation
d.Schedule development
e. Schedule control
f. Identification of Rate limiting steps in a study
i. Long start up timelines (EC)
ii. Clinical trial agreement
iii. Availability of patients
iv. Resource transition
g. Accurate projections at the time of feasibility
h. Importance of Inter-activity logical relationship
i. Plan for the duration of study, closely track
j. Scheduling activities from SSV to SCV (pre-screening to study closeout)
k. Compliance to monitoring and auditing

Project cost management

This includes resource planning, cost estimation, cost budgeting and cost control. For this physical resources needed are identified, cost estimates provided, resources budgeted in the CTA and expenses closely monitored.
Project Quality Management

There has to be quality planning with both QA and QC in place. The Quality policy should have a clearly defined scope with SOPs and regulation in place. Internal QC
monitoring should give trend analysis and have to be enhanced by external audits and inspections. Adherence to protocol, GCP and applicable regulatory guidelines, fulfilment of the Investigator’s Obligations, Monitor Compliance, and timely communications are checked. Regular and corrective training and other proactive steps must be taken to improve Quality of a project.

Project Risk Management
Risk Identification, Risk Analysis (Qualitative and Quantitative), Risk response plan and Risk monitoring and control form the planning of project risk management. Essentially it is all about WHAT COULD GO WRONG. For example, slow product availability,
unexpected SAEs, slow IRB approval, slow recruitment and increased expenses could all pose risks to the project over budget.

A risk management plan would identify & prioritize risks. A Qualitative/ Quantitative analysis is followed by a plan for response to the risk. Monitoring and control are also
planned.