Clinical Project Management

CliniExperts ensures competent management of time,resources and budget throughout the project.We assist our clients for evaluation and selection of qualified sites, right up to the project closure.


Clinical Project Management

CliniExperts is your Clinical Research partner that drives operational efficiency and engages every phase of your clinical trials. Our Clinical Project Management team possesses all the skills to expertly guide your organization to manage all relevant data to strengthen your research goals with the utmost integrity.

We believe in a collaborative approach for the success of all our projects, which is why our Project Manager plays a pivotal role in being the central point of all communications. Our Clinical Project Manager and the team helps clients by providing active training, support, and review of the clinical data from an operational standpoint. CliniExperts has an arsenal of experience and expertise to provide timely functional solutions to tackle the most challenging project hurdles and make sure that your project gets delivered on time with zero compromises on its quality.

Your assigned Project Manager will be available at any time while conducting the study, where their role begins with the site proposal, follows through with the evaluation and selection of the qualified sites, until the closing. At CliniExperts, our dedication and expertise are the product of years of industry leadership that ensures thorough mitigation and clinical trial risks.

Why Choose a CliniExperts CRO?

  • We prepare the required study materials like the protocol, case report forms, and informed consent documentation for a seamless transition.
  • We provide the most suitable Project Manager to oversee the ambit of functions that range from budgeting and travel management to IMP and data management, making us a strong contender in clinical project management in the industry.
  • We establish the documentation necessary for the Ethics Committee's approval.
  • We also prepare material and provide any support needed during the initial meetings with the DGCI and other regulatory bodies.
  • We make pre-trial visits to upskill the site staff regarding the protocol, applicable regulations, study materials and Good Clinical Practices.
  • We maintain active communications with the clients keeping them updated on the status of the project, including recruitment, outstanding issues, project deviations and other important tasks of the study in a timely manner.

Precise Delivery at Each step

It takes a special team with excellent technical expertise to oversee clinical trials. Our clinical project management team is built with professionals and managers who possess the flexibility to make prompt decisions, negotiate and troubleshoot at a moment's notice. With an eye for the slightest details and an expansive understanding of the Indian clinical trial regulations and good clinical practices, CliniExperts is your best bet for your next clinical project management partner. Our team also ensures that your research complies with all the prerequisites and necessary regulations. CliniExperts also protects subjects' rights and ensures that your data is accurate, complete and verifiable from the source.

CliniExperts' Project Management Services

We are here for our clients at every phase, be it:

  • Site selection and feasibility assessment
  • Planning and leading meetings
  • Patient recruitment strategies
  • Ethics Committee and regulatory formalities
  • Project management and overseeing Phase I-IV clinical trials
  • Third-party vendor management
  • Developing project plans and timelines
  • Commencing activities and research initiation
  • Clinical monitoring
  • Managing data support teams from the protocol development process to the clinical study report
  • Maintaining and reporting pharmacometrics deliverables

We provide our clinical project management services for products such as drug trials, medical devices and IVD, biologicals, and consumer claims. CliniExperts contributes significantly to the world of medicine and sciences to support the most renowned brands in making groundbreaking studies and releasing revolutionary products every time.

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Frequently Asked Questions

What is the provision of pre-submission meetings in the New Drugs and Clinical Trial Rules, 2019?

As per the new provision of pre-submission meetings, applicants can discuss their projects with the regulators and subject experts by paying a certain fee, before making actual submission to the regulator, for seeking guidance about the requirements of law and procedure applicable for their projects.

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