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*Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Project Management Services

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The management of clinical research projects is a critical part of their success. At Protheragen, we offer complete clinical trial lifecycle project management services to provide support for the conduct of clinical trials according to the requirements set by the governing bodies.

Introduction to Project Management

Clinical research project management employs specific techniques to manage planning and control of every aspect of the clinical trial process. This includes resource coordination, timeline management, and ensuring regulatory compliance. The general objective is to finish with a clinically controlled efficient trial while meeting target budgets and the highest standards of data quality and ethical responsibility.

Project Management cases. Fig.1 Example of a project management. (Croxatto A., et al., 2017)

The Role of Project Management in Clinical Research

Stakeholder Management
A clinical trial has a wider scope and many people are involved You have the sponsors, investigators, participants, and regulatory authorities. According to the trait, the Project Manager takes the key role of a focal person and opens channels of communication and the required modes of information dissemination.
Resource Management
It is in the hands of the project managers to allocate the duties to many participants of the trial. If there are more than enough of people in one area they can allocate them to different roles and manage the finance of the project ensuring that budget is spent on only what is necessary for the trial goals.

Risk Management
In every project, it is a prerequisite to assess the risks associated with that project and implement the right measures to prevent it from affecting the project. By doing this, the Trial is more probability to get going per schedule and with minimal interruptions.
Security of Data
The position of a project manager comes with the responsibility of overseeing the data management to make sure the data is properly collected, recorded, and analyzed reliably. This entails utilizing a reliable and validated automated data management system as well as putting in place checks and controls to identify and rectify errors.

Our Services

In the clinical trial's lifecycle, we assist with our multi-faceted project management services at Protheragen. Our managers have extensive expertise, which guarantees that all clinical tests adhere to the required parameters.

Project Planning and Monitor

Protheragen's project managers are a major force towards possible success as they prepare holistic plans for their respective management projects with various timelines, resource allocation, risks management strategies and provide supervision.

Stakeholder Management

For Protheragen's project managers, communication between all stakeholders, clients and other parties including the sponsor and investigative sites is much facilitated by their contact with functional service providers.

Timeline and Budget Management

To guarantee the integrity of a project, Protheragen's project managers closely control and supervise the execution of its trial while using the timely funds allocated for it.

Regulatory Compliance

For Protheragen's project managers, ensuring of all activities performed in the scope of the trial is consistent with applicable laws and policies such as GCP is important, as this makes the regulatory review more efficient.

Vendor and Third-Party Management

Protheragen's project managers handle the choosing, contracting and management of all the third parties, vendors and service contractors involved with the trial.

Risk Identification and Mitigation

Protheragen's project managers are actively engaged with other members of the study team and conduct identification of risks.

The project managers at Protheragen are well-versed in various therapeutic areas, allowing them to render custom assistance for all studies in an appropriate manner. If you are interested in our services, please feel free to contact us.

Reference

Croxatto, Antony, and Gilbert Greub. "Project management: importance for diagnostic laboratories." Clinical Microbiology and Infection 23.7 (2017): 434-440.