Not sure what to expect?
When partnering with a Functional Service Provider (FSP) like OWL Oncology Research, clients can expect a collaborative approach that balances control and flexibility. We integrate seamlessly with the client's internal teams, offering specialized expertise while allowing the client to maintain strategic oversight of their clinical trials. This model provides the adaptability to scale resources in response to project demands. Clients benefit from improved productivity and the ability to pursue development objectives without giving up control over their processes.
Flexible Infrastructure
Unlike traditional outsourcing models, our FSP flexible infrastructure provides specialized talent and operational support that can be scaled up or down based on project demands. This modular approach allows clients to retain strategic control while leveraging external expertise without committing to rigid, long-term contracts. We integrate seamlessly with in-house teams, to ensure consistent workflows and knowledge transfer, minimizing disruptions and inefficiencies. Additionally, we offer customized support, whether for a single function like monitoring or a broader scope of clinical operations. The result? Clients can remain agile in a constantly shifting regulatory and scientific landscape.
"Great company with great experience."
“Great company with great experience. Have worked with them for many, many years and the team at OWL has been instrumental in supporting several regulatory approvals.”
– VP and Director, 5 small biotech clients
Process & Timing
1. Discovery
The client and OWL discuss the project scope and define details needed to build a customized proposal.
(about 2 weeks)
4. Onboarding & Training
OWL staff is onboarded, provided with necessary software, and receives initial project training.
(usually 1 week)
2. Service Agreements
Necessary agreements are negotiated and executed before work begins.
(about 2-4 weeks)
5. Integration & Monitoring
OWLs are integrated into the team, with ongoing check-ins to ensure alignment with client objectives.
(ongoing)
3. Candidate
Selection
OWL submits candidates for consideration. Client may conduct independent interviews and confirm approval of resources.
(about 1-2 weeks)
6. Adapting to Trial Needs
OWL management stays closely engaged with clients, holding regular check-ins to align on progress, resource needs, and feedback.
(ongoing)
This is only a sample timeline for an average clinical trial. Please get in touch so we can go over the specific needs of your upcoming trial, and discuss what timing is possible for you.
Fee Structure
At OWL Oncology Research, we understand the complexities of clinical trials and the importance of efficient budgeting. Our fee structure is designed to be straightforward and transparent, ensuring that clients can easily anticipate costs without hidden surprises. By providing clear and concise budgeting, we enable our partners to focus on advancing oncology and rare disease research with confidence and clarity.
Financial Benefits of Working With an FSP
When evaluating the financial implications of outsourcing models, pharmaceutical companies often find that partnering with a Functional Service Provider (FSP) offers distinct advantages over traditional Contract Research Organizations (CROs). The FSP model enables sponsors to outsource specific functions of a clinical trial while retaining control over data and processes, leading to cost savings and operational efficiency. This approach allows for flexible resource allocation, reducing administrative burdens and enabling better forecasting and scalability. In contrast, full-service outsourcing with CROs can involve higher costs and less control over trial conduct. Collaborating with an FSP provides a more tailored and cost-effective solution for managing clinical trials, enabling better forecasting and scalability, without the hassle of complicated budget grids and hidden costs.
Our Experienced Workforce
OWL Oncology Research only works with seasoned professionals with at least a decade of experience. Here are some roles most commonly serviced by our industry veterans.
Clinical Operations & Trial Management
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Clinical Monitoring
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Project Management
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Clinical Trial Management
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In-House CRA Support
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Clinical Trial Assistants
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Process development
Medical Writing
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Protocol Development
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CSR Writing
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Safety Narrative
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Scientific Journals
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NDA and IB writing
Regulatory Affairs & Compliance
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Regulatory Affairs Manager
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Regulatory Affairs Specialist
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Compliance Officer
Site Management
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Clinical Site Liaison
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Feasibility Manager
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Site Activation Specialist​
Medical & Regulatory Affairs
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US and Global regulatory submissions
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Inspection Readiness
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Regulatory Compliance
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Medical Monitoring
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Trial Master File Specialist
Quality Assurance
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QC Oversight Monitoring
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GCP Site audits
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GxP Vendor audits and qualification
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Mock inspections
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SOP and QMS Development
Don't see the expertise you need? This is just a partial list! Please get in touch so we can connect you with folks who have the skillsets you require.