Project Management

We recognize that Project Management is the bedrock of a successful clinical study. An outstanding Project Management team over-communicates with the sponsor's team, keeping them informed of every detail, positive and otherwise.

Navitas Life Sciences takes a team approach to project management. Each team is composed of a highly dedicated interdisciplinary team led by one Project Manager who is the lead point-of-contact throughout the study.

Navitas Life Sciences has an outstanding track record of continuity in our project management teams, which significantly facilitates communication with the sponsor's study team.

At Navitas, our project managers have proven expertise in clinical and late-stage research.

Our project managers:

  • Serve as a primary resource and point of communication for the clients and project teams
  • Provide direction and leadership to the project teams, including specifications for quality, time and cost of deliverables
  • Utilize capabilities, systems and processes to assure efficiency and accuracy throughout the project
  • Follows industry risk management process, addressing potential obstacles that may impact study timelines and / or quality.
  • Maintains a flexible, can-do approach to address issues proactively and innovatively
  • Project teams are trained for each study with regard to the study's medical background, study goals, identification and prevention of pitfalls and study plan.

Project Managers have up-to-date knowledge of regulatory compliance at sites and at CRO HQ by local and global regulators. They have several years’ experience in clinical research, select therapy areas, and the specific needs of biotech, device, generic and pharmaceutical sponsors. They possess managerial capabilities to work with investigators, IRBs, site personnel, sponsor team, vendors and subcontractors. Project Managers are also trained in ‘soft skills’ for effective inter-personal relationships. They are familiar with aligning site and CRO trial management systems to the sponsor requirements.

Satisfied Clients

Over the last 30 years, we have served global sponsors in pharma, biotech, medical device, diagnostic, generic and consumer health companies across Europe, US and Asia. We are proud that our work has led to long standing relationships from 5 to 30 years of continuous service with leading sponsors.

Risk-based Monitoring

In a world of continuous change, clinical trial management has always been perceived as an area where much could be achieved in a more efficient manner.

Monitoring practices today have evolved with a more proactive and targeted approach by using advanced technologies.

Understanding our customer needs, supported by the recommendation of the US FDA and EMEA, we have developed in-house solutions to provide services of risk-based monitoring.

With the use of validated analytical tools integrated with various information sources, the system triggers potential risks and recommends effective management on a real-time basis.

This proactive assessment and elimination of risks in trials drives the quality to the next level.

Monitoring

Our monitors (CRAs) attend in-house education courses and are kept up-to-date with the latest information on current and upcoming developments. Project Managers and CRA Supervisors discuss site-specific findings and provide guidelines on which metrics and issues require consistent follow-up. We conduct annual ICH GCP exams for our CRAs to ensure they perform to the highest standards.

Monitors are based regionally and are familiar with the local standard of diagnosis & care, local regulation, local languages and local conditions. They maintain consistently good relationship with the sites.

At Navitas Life Sciences we ensure the highest quality review of data and effective interaction of our well trained and skilled clinical research associates (CRAs) with study sites.

Navitas Life Sciences monitoring teams deliver faster, efficient investigator site support and data oversight. Our CRAs conduct on-site monitoring visits throughout the study to:

  • Ensure fast recruitment at the site
  • Ensure regulatory compliance
  • Oversee data collection
  • Review source documentation and case report forms
  • Resolve data queries

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