Clinical Project Management
Zanteris can provide you with the support you need
Leveraging 14+ years of experience within the Life Science industry, with 10+ years in Project Management positions, I am offering my experience, knowledge and expertise, to help small and mid-sized providers in the clinical research industry thrive. Drawing from my Clinical Operations, financial, and leadership expertise, I partner with organizations to optimize their implementation of a new clinical trial or program, processes and team development. I help guide organizations to maximize opportunities and overcome challenges within the complex clinical trials environment, providing customized consulting services tailored to meet each client’s unique needs.
With a significant amount of data to analyze and process, documents to monitor, and regulations to follow, effective outsourcing appears to be a cost-effective approach.
We have a structure that meets the needs of both the biotech and pharma industries. We partner with the appropriate organizations to provide the right FSP model.
As a Functional Service Provider, we ensure that you get the necessary expertise in the field of need (biotech and pharma industries). Inadvertently, the utilized expertise helps increase the quality of clinical trials.
As a functional CRO, Zanteris is also able to optimize clinical studies without providing all resources. With our effective processes, delegating major tasks in clinical trials helps improve the quality of clinical trial analysis and core operations.
Get access to necessary resources in either biotech or pharma industries. As functional service providers, you can benefit from our employee services and benefits, line management, and technology. FSP like Zanteris give the best service while remaining independently responsible for the cost of resources.
Some of the major downsides of clinical trials is the cost, time, and resources that it takes from firms. For this reason, FSP can help track advancement and other core work processes in clinical trials. These efforts make pharma and biotech companies cut down on cost, time, and also resources.
At Zanteris, our FSP model is designed to function effectively. We set realistic goals, create effective plans and schedules, utilize relevant resources, make necessary assumptions, and achieve major decision points and milestones. Zanteris is here to provide the support needed for continuity in Clinical Operations.
CLINICAL PROJECT MANAGEMENT SERVICES
- Project planning and oversight – Proactively ensuring timely delivery of project milestones
- Overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements
- Primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
- Budget expert – Assisting our clients to ensure that the clinical study is completed within budget
- Lead and motivate the project team to ensure quality, timelines and budget management
- Coordinate activities and deliverables of all study conduct third-party vendors and proactively identify and manage issues
- Performance Quality – Ensuring that each step of your clinical trial is completed with high quality results
- Risk planning and management, mitigation/contingency
- Third-party vendors management
- Management of Investigator Meetings
OUTSOURCING SOLUTIONS
Are you looking to hire a professional clinical operations manager or a clinical trial project manager?
We believe outsourcing clinical project management services can also help to make your business more flexible and agile, able to adapt to changing market conditions and challenges while providing cost savings and service level improvements.
The flexibility you need
- Increased efficiency – choosing us as an outsourcing company that can help you achieve a more productive, efficient service, and with a greater quality
- Controlled costs – competitive offer. Cost-savings achieved by outsourcing can help you to focus in other areas of your business
- Resources as per your needs – Full or part-time, short or long-term staffing solutions
- Dedicated special Project Manager or Clinical Operations Manager / Director
- CRO Oversight
PROGRAM – PORTFOLIO MANAGEMENT
Portfolio planning and management is a key input to the overall success of partnership with Customers in order to bring a specific to market authorization.
Transparency and engagement among the parties in plans for outsourcing as early as possible has the following benefits
- Enables Customers to receive input and intelligence during the planning stages of a trial/program/protocol
- Enables Customers to successfully predict resource needs, locations and specific expertise
- Provides better opportunity for planning and study feasibility, leading to more accurate trial timelines
Program – Portfolio services
- Oversight of the conduct of a program/ portfolio of studies
- Management of scope of work, goals, quality deliverables, resources, risk and other project management activities
- Ensure all studies within a program/portfolio are conducted to reflect the therapeutic or customer requirements
- Ensure the study is going according to customer quality standards, SOPs, ICH-GCP, or any regulatory requirements
- Manages contract and financial aspects of assigned projects
What it’s like working with us
We greatly appreciate that you are clearly looking out for our best interest and providing suggestions to enhance the entire clin ops segment. Many consultants would simply complete the tasks assigned; however, your team is adding much more value. We truly view you as part of our family.
Chief Development Officer
Clinical Informatics
US Biotech