OUR MISSION
is to elevate and fortify your oversight capabilities.
Through expert guidance and specialized services, we provide a structured pathway for sponsors to achieve their oversight objectives, ensuring every step is transparent, impactful, and aligned with their vision.
What’s the outcome of using specialized oversight services?
1. Improved Trial Progress:
Focus on advancing your trial. While oversight remains your responsibility, we are here to streamline the process. We’ll expertly implement an oversight plan, organize all related activities, and consistently provide you with feedback on the outcomes. Your oversight, enhanced and simplified.
2. Ensuring the Trial Flow:
By identifying issues in real-time through oversight, your trial advances without unexpected delays or roadblocks.
3. Compliance with Regulatory Standards:
In a world where regulatory bodies are zooming in on trial oversight, our support ensures you meet their requirements. The outcome? A smoother journey to registration and market success , which means patients can sooner receive the vital treatments they deeply need.
4. Budget control is boosting your Investors
Prevent costly delays by anticipating obstacles. Investors maintain their confidence and support as your study stays firmly on course.
Meet the founder Smaranda Doucet
Who we are
“In 15 years, I’ve worn many hats: entrepreneur, freelancer for start-ups, to leadership within CRO, working hand-in-hand with sponsors. I’ve experienced the intricacies of drug development from every angle, understanding the unique challenges each role brings.
FlowTrial stems from this comprehensive experience. It’s more than a solution, it’s a reflection of my journey, assuring you that I genuinely know where you stand and I’m being committed to provide support and expertise.
Together, we can ease the complexities, through cooperation and partnership, step by step”.
Authentic Communication:
Genuine dialogues aimed at achieving clarity and understanding, paving the way for meaningful changes to take place.
True Partnership:
Standing by your side, every step of the journey.
Transparent Operations
Commitment to openness as the cornerstone of our actions.
Unwavering support
Always here, ensuring a smoother journey for you.
Let’s chat!
Set up a 30-minute session to discuss your needs and explore how we can help. Select a date and time that works for you.
How we work
ICH-GCP Addemdum
The sponsor must maintain OVERSIGHT of all trial-related duties and functions performed on its behalf, which includes trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
ICH-GCP
The sponsor is responsible for ensuring that trials are conducted, and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s).
SERVICE PACKAGE OPTION 1
HOW?
Oversight Programme Training for Sponsors
(we train you to handle it yourself)
HOW?
Training
& Guidance:
Empower your staff with oversight skills to perform sponsor oversight effectively.
Oversight
Plan Design:
Providing a comprehensive blueprint for the Sponsor Oversight Plan, we furnish a universal template that can be tailored to align with your trial’s unique needs .
Regulatory Compliance
Templates:
Access to essential oversight templates and documents, ensuring compliance with regulatory body requirements.
Applied Oversight:
As part of the training programme, we conduct hands-on oversight visits alongside your designated teams, translating theory into tangible, actionable experience.
Universal
Oversight Training
Through our oversight training, you acquire versatile insights that are easily applicable to any clinical trial you undertake.
SERVICE PACKAGE OPTION 2
HOW?
Full Oversight Service
(we handle it on your behalf)
Strategic Oversight Enhancement:
Our management of oversight is defined by its thorough documentation practices, upholding the highest standards of quality and compliance.
Tailored Oversight Planning:
We meticulously craft the sponsor oversight plan, ensuring each aspect is validated and receives approval from our Quality Director. Complementing this, we document all essential oversight templates, which are rigorously reviewed and sanctioned by our designated quality personnel.Throughout this process, the sponsor remains actively involved, ensuring alignment, transparency, and shared understanding.
Elevated Sponsor Insights
Working as an extension of your team, we provide regular and insightful updates, on every aspect of oversight process, through a feedback mechanism with the Sponsor. This enhanced transparency equips you with the clarity necessary for making decisive and impactful decisions.
Why us?
New to
Clinical Trials?
Diving into the complex world of trials? Our oversight services ensure control and early obstacle detection.
Outsourced
All Activities?
If you’re relying heavily on CROs and vendors, we can support you oversee their work, ensuring they stay aligned with your vision.
Limited resources for Oversight?
Rest assured, we’ve got you covered with our comprehensive oversight services.
Overwhelmed with Oversight Documentation?
Let us handle the meticulous oversight documentation, providing insights without the hassle.
Global trials?
Our experts ensure uniform oversight standards across all regions, providing a harmonized approach.
Uncertain about oversight and where to begin?
We’re here to train, guide, collaborate, and execute it alongside and for you.
Seeking Peace of Mind?
Focus on the bigger picture; we’ll keep the oversight details aligned and in check.
Background
We were presented with a challenging scenario: 50 US sites struggling with recruitment, a track record of non-compliance, and a lack of engagement.
Challenges
• Sites consistently underperformed on their recruitment targets.
• Historical issues of non-compliance and engagement.
• Misinterpretation of the trial protocol and other study documents.
Our Intervention
• Performed targeted oversight visits to grasp the on-site dynamics.
• Uncovered obstacles, including protocol misunderstandings.
• Shared our findings with the sponsor to guide informed actions.
Results
• Sponsor coordinated with the CRO for necessary training.
• Significant improvement in recruitment and study quality.
• US transformed from a lagging region to the top-performing region globally in both recruitment numbers and quality.
DOUCET SMARANDA, CEO
+4 0748 137 012
smaranda.doucet@flowtrial.net
Contact
Let’s chat! Set up a free 30-minute session to discuss your needs and explore how we can help. Click the button below to pick a time that works for you.
Let’s chat!
Set up a free 30-minute session to discuss your needs and explore how we can help.
Click here to pick a time that works for you.
