Skip to content
Zanteris - Logo
  • Home
  • Company
    • Our Values
    • Our Approach
    • Areas of expertise
    • About us
    • Resources
  • Solutions
    • Clinical Operations Consulting
    • Clinical Project Management Resources
    • Human Efficiency Consulting
    • Strategic Partnerships
  • Insights
  • Contact
Menu
  • Home
  • Company
    • Our Values
    • Our Approach
    • Areas of expertise
    • About us
    • Resources
  • Solutions
    • Clinical Operations Consulting
    • Clinical Project Management Resources
    • Human Efficiency Consulting
    • Strategic Partnerships
  • Insights
  • Contact
Successful Project Management
July 21, 2022

Successful Project Management in Clinical Research

“Management is, above all, a practice where art, science, and craft meet.” Henry Mitzberg claims that management is the convergence of different skills, knowledge, and discipline. These elements are being utilized to carry out whatever it is that an individual or group is managing. These key attributes can clearly define the outcome of whatever it is that is being managed. Whether they are people, processes, or products, management brings order, goals, and vision to the project being fulfilled.

 

Is Clinical Research a Project

The Project Management Body of Knowledge, or also known as the PMBOK Guide, explained that a project is anything that can be categorized as “a temporary endeavor undertaken to create a unique product, service, or result.” Using this definition, it could be inferred that a Clinical Trial can also be considered as a “project” for several reasons. First, Clinical Trials are temporary studies because they have clear definitions of its starting and end points. Second, Clinical Trials aim to formulate, study, or experiment new devices, diseases, or drugs. Therefore, it can be concluded that, using the definition by the PMBOK, Clinical Trials are also projects.

 

Project Management in Clinical Trials

As reported by Goodarzynejad and Babamahmoodi in the their published article “Project Management of Randomized Clinical Trials: A Narrative Review” (2015), they stated that, “Clinical Trial Management is most simply defined as that an organization follows to ensure that quality (defined as minimized risks and clean data) is delivered efficiently and punctually.” Processes that are involved in running a Clinical Research are being executed in accordance to the qualities and standards that every protocol defined in the project and also to the schedules that need to be adhered to.

Furthermore, according to Madhuri Patel in his published paper “Effective Clinical Project Management to Streamline Clinical Trial” (2018), he stated that, Clinical Research are instances of projects which take systematic efforts to answer scientific and health related questions or problems.” It is very obvious and common to a Clinical Trial to have countless processes and data being monitored, enforced, and evaluated all at once. So, clearly, Project Management disciplines should be implemented in order to maintain the orderliness, accuracy, and quality of the study results. After all, careful and critical handling of data must be ensured because the scientific approach is the most ideal approach since Clinical Trials are dealing with various components such as study approaches, recruitment processes, laboratory investigations, product examinations, data gathering and analysis, materials and site management.

 

5 Steps of Project Management

According to Hope Cullen in her book “Effective Project Management for Clinical Trials”, a Clinical Trial can be broken down into 5 Stages: Initiating, Planning, Execution, Monitoring & Controlling, and Closing.

Initiating phase is where the project’s vision, initial project scope and limitation, and stakeholders identification are being defined.

Planning phase is where the total scope of the project is being established, schedules, risks, goals, stakeholder management, and funds are being built.

Execution phase is where the acquisition, development, and management of teams are being done. This is where quality assurance, communication, and engagement among the researchers and stakeholders take place. This is also where the goals are being achieved.

Monitoring & Controlling phase is where big decisions are being made: to terminate, adjust, or continue. This is also where the adjustments in work, scope, schedule, cost, and risk are being done.

Closing phase is where the project ends using a formal process.

 

Tools for Success in Managing Clinical Trials

According to Farell, Kenyon, and Shakur, in the published paper “Managing Clinical Trials” (2010), they state that, “Many clinical trials fail to deliver because of the lack of a structured, practical, businesslike approach to trial management. The human and financial resources for conducting a randomized trial is finite, so it is crucial that every effort is made to ensure that a trial is implemented simply and managed efficiently.” The fate of a study, whether it becomes a success or a failure, is dependent on how the trial is being managed. A Clinical Trial is composed of countless data, various people and processes working simultaneously. So, it is just fair to say that competent, reliable, and skilled people are required to work in the medical field.

 

Project Manager

Clinical Trials have grown in complexities and competition over the years. According to Patel (2018), the role of a Clinical Project Manager is to balance scientific integrity and business interest. Furthermore, he claimed that a Clinical Project Manager should possess these key qualities: Knowledgeable, Organized, Trusting, Approachable, & Transparent.

The Project Manager is the link between the investors, PI (Principal Investigators, and the researchers to be able to communicate the plans that are agreed upon. The importance of Project Managers are being recognized by industry and regulatory bodies. To be exact, Project Management Institute plans to be governed by the ISO or International Standards Organization to have PMs certified.

 

Project Plan

As former US President Benjamin Franklin said, “By failing to prepare, you are preparing to fail.” A goal without a plan is just an idea. Clinical Trials are big, multimillion projects that involve countless processes and regulations. To be able to achieve its ultimate goals, it must achieve careful planning first.

According to Patel (2018), “Clinical trials have the same features as other business projects as defined in the field of project management.” The features of business projects may include the following: Definition of Objectives, Team Recruitment, Timelines and Timeframes, Resources and Funding, Designation of Tasks.

The Plan of the Clinical Trial should clearly state what the researchers are achieving, how the funds would be utilized within a given amount of time. The plan should also distinguish how each process will be monitored to ensure that all of the elements are in accordance and adherence to what the project is trying to achieve and be delivered as organized.

 

Conclusion

Management is truly the convergence of different skills, knowledge, and discipline; put together to guide an endeavor to its success or failure. In Clinical Research, proper management is imperative to be able to carry out all of the necessary tasks in order to achieve what the study is trying to achieve. After all, tools in a toolbox won’t fix anything unless a carpenter or a mechanic uses them.

 

References:

https://www.imperialcrs.com/files/Project_Management_Ebook_Final.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4586955/#A11602R9
https://juniperpublishers.com/ctbeb/pdf/CTBEB.MS.ID.555937.pdf
https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-78

 

Featured Insights

Loading...
1202491940197073.gOUSATFDelIUtv00a9tS_height640
May 25, 2022

Factors To Consider In Making a Clinical Research

Clinical Research is being done to extrapolate, explain, and explore various medical concerns through data and experimentation. Basically, the objective...
READ MORE
1202491940197071.pJ88VakUjZQWAZsXpAJl_height640
May 25, 2022

Keys To Success With Clinical Trials

Clinical Trials is a specialized area of study that faces an ever-changing environment. The shifts in this field are happening...
READ MORE
1202491940197069.2ayavKakJhUoeVrFuELP_height640
May 25, 2022

The Challenges of Clinical Research

Working in a Clinical Project is challenging but rewarding. It also requires the support of many different stakeholders. These include...
READ MORE

What It’s Like Working With Us

… a good sense of what it takes to successfully navigate challenging clinical trials to achieve success on behalf of his customers. In particular, his data and information expertise gave him the ability to mentor, support and coach teams towards a more data driven approach to strategy and outcomes. …

Senior Vice President

Clinical Informatics US
CRO Company

  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
©2022 Zanteris – All Rights Reserved
  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
  • Privacy policy
  • Cookie policy
  • Legal notice
  • General terms
  • Terms of use
Scroll Up

We are using cookies to give you the best experience on our website.

You can find out more about which cookies we are using or switch them off in settings.

Zanteris - favicon
Powered by  GDPR Cookie Compliance
Privacy Overview

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Cookies strictly necessary

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms.    You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

If you set your browser to block or alert you about these cookies, but some parts of the site will not then work.

3rd Party Cookies

This website uses Google analytics cookies to store unique user data in order to get detailed data over how users use and navigate on the website.

We also use social media buttons on our site which allow you to share content and interact with your social network on platforms like Linkeldin and Twitter. These social media platforms may set their own cookies on your device. We do not control the settings of these cookies so we suggest you check the social media website for more information about their cookies and how to manage them.

If you'd like us to improve our website, please keep this cookie activated.

Please activate the "cookies strictly necessary"; so, we can record your choice!