Project Management

Flexibility, innovation, and integrity guide our approach to project management and leadership for the success of your clinical trials.

A Seamless Extension of Your Organization

Our experienced teams here at Siron Clinical become a seamless extension of your organization, through our deep scientific capability and our project management expertise, our goal is your success, while saving time and money.

Why choose Siron Clinical?

One Single Point of Contact

Working with us, you’ll have a single point of contact, ensuring  oversight, keeping the connection between sponsor and all participating partners, and maintaining site management.

Effective Coordination

We become a seamless extension of your organization and take pride in saving you time with effective coordination. Our goal is to realize your success.

Project Management Services

Developing and tracking study timelines

Ensuring all activities are within scope and budget

Maintaining + reporting on quality metrics

Coordinating and executing Clinical Trial activities

Developing and implementing risk mitigation plans

Clinical team management

Central point of contact for client

Our Process

When you work with us, we can expect a three step process including start up, execution, and closure.  Siron Clinical Project Managers have excellent organizational, motivational, and management skills and are qualified to take on the all responsibilities necessary to ensure success.

Our process includes these steps:

Start Up

Before a project begins, we have a first study kick-off meeting involving the applicable members of the project team, Siron Clinical team, and other vendors.

This phase includes:

  • Study kick-off meeting
  • Study team training
  • Regulatory submissions
  • Timeline management
  • Develop project/monitoring plan
  • TMF setup

Execution

Our approach in project management focuses on flexibility, innovation, and integrity for the success of your clinical trials. Our experienced team will become a seamless extension of your organization.

This phase includes:

  • Project and site management
  • Team meetings
  • Study tracking through completion
  • Budget, timeline, and vendor management
  • TMF management
  • QA/QC management

Closure

Following project execution, we move into the closure of the project.

This phase includes:

  • Manage timely query resolution
  • TMF management and reconciliation
  • Timeline management

 

Our Services

Project Management

Flexibility, innovation, and integrity guide our approach to project management and leadership for the success of your clinical trials.

Clinical Monitoring

We provide passionate strategic knowledge, specific guidance, and expertise for study execution across multiple therapeutic areas.

Quality Assurance / Control

We pride ourselves on accuracy and integrity through a continual and dynamic process when it comes to quality assurance and quality control.

Regulatory Submissions

We manage the entire Regulatory Submission process carefully and efficiently, bringing the benefits of new treatments to patients sooner while maximizing research investments.

How is Clinical Trial Success Defined in Europe?

Bringing a product further down the development pipeline often requires conducting clinical research in Europe. However, navigating varied local regulations specific to each country, EMA, and cultural differences can be challenging. Download our RFI on to discover more about our insights, approach and experience.

Experience Matters

We offer unparalleled knowledge, support, guidance, and extremely experienced clinical research professionals to the biotechnology, life science, and medical device industries. We are committed to leading the development of new and advanced treatments.

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