Excellence in Clinical Operations
Let us be your first port of call to help you on your clinical trial journey...
Excellence in Clinical Operations
Let us be your first port of call to help you on your clinical trial journey...
Let us be your first port of call to help you on your clinical trial journey...
Let us be your first port of call to help you on your clinical trial journey...
We set up BlueGreen Clinical as we saw a need for a ‘one-stop shop’ for clinical operations, and wider clinical development, to help ensure Biotech and Pharma run successful trials and have solid foundations to build from.
Our clients use our knowledge & experience of working in a successful Biotech to start their trials faster and to finish ‘on time’ & ‘on budget’ with high-quality, compliant data - all with reduced risks.
These are just some of the things we can give to you - let us make your company the best it can be.
• Strategy and consultancy for all aspects of clinical operations and GCP.
• Clinical Operations transformation - whether you are thinking of changing your model and ways of working or restructuring your clinical operations team.
• Rapid and transformative review of documentation - such as protocols, CRO proposals, systems specifications (IRT, eCOA, etc.) to ensure success and reduced risk.
• Expert review and provision of process & tools by experienced Clinical Operations professionals to make sure you have the solid foundations to build for success.
• Inspection preparation for your clinical operations to make sure you have a successful Inspection and get your drug approved!
• Provision of expert training and lessons learned experience in clinical operations to give you the benefit of our experience of helping a Biotech to become a successful Pharma company.
• Expert guidance during selection and management of Vendors - this is key to a successful trial and we can provide you with our expertise, the questions to ask and hold your hand along the way.
• Are you confident that everything is suitably robust with your trials and processes? Let us help you with our Clinical Operations 'Tune Up'. This will make sure you get the best out of your trial and have success in your Inspections.
• We built successful teams in clinical operations and can help you to build/expand your own clinical operations team when needed. Having the right people is key to success.
• Clinical Trials is a team effort and we have amazing experts in many other areas of clinical development we can introduce you to, so your company can have the best knowledge and experience going forward.
We are not a CRO, but instead your trusted clinical operations consultants who can roll their sleeves up, guiding you each step of the way on your exciting and meaningful journey.
Don't hesitate to get in contact to see how we can help you...
Let us be that friendly help and advice utilizing our many years of clinical operations experience. We can support you with Clinical Operations transformation (new ways of working, departmental structure), strategy, general advice, or even if you want our review on something you're working on, we can help to put your mind at ease. We
Let us be that friendly help and advice utilizing our many years of clinical operations experience. We can support you with Clinical Operations transformation (new ways of working, departmental structure), strategy, general advice, or even if you want our review on something you're working on, we can help to put your mind at ease. We believe that every Biotech and Pharma company should have the process, tools and knowledge to deliver high-quality clinical trials and give you the best chance of success. We can support you with setting up all the aspects of clinical operations you may need to get a clinical trial started.
We also have a wide network of Associates who can help you in all aspects of Clinical Development.
Let us help ensure you have solid foundations in clinical operations as you move into clinical trials. With an Excellence in Clinical Operations (ECO) mindset, we can provide you with the strategy needed to best build your clinical operations along with tailored fit-for-purpose processes (e.g. SOPs, Forms and Templates), tools and system
Let us help ensure you have solid foundations in clinical operations as you move into clinical trials. With an Excellence in Clinical Operations (ECO) mindset, we can provide you with the strategy needed to best build your clinical operations along with tailored fit-for-purpose processes (e.g. SOPs, Forms and Templates), tools and systems (e.g. Quality Management System). Anything you may need for starting or building a clinical operations team, we can assist you with. Alternatively we can work with your existing team and also offer an 'ECO Tune Up' to see if your clinical operations can be improved.
Finding a vendor to work with can be a big leap of faith. With our experience of directly running clinical trials, and also overseeing CROs, let us help you make the right decision. We can work with, or act as, your clinical operations team. When it comes to reviewing proposals, selection/oversight meetings with the vendors, and importa
Finding a vendor to work with can be a big leap of faith. With our experience of directly running clinical trials, and also overseeing CROs, let us help you make the right decision. We can work with, or act as, your clinical operations team. When it comes to reviewing proposals, selection/oversight meetings with the vendors, and importantly ensuring the correct SOPs and plans are in place as needed, we can be there for you. By all means you can also use us as that clinical operations soundboard when questions or issues arise.
Matt and Steve have spent nearly 20 years working in Clinical Operations for GW Pharmaceuticals, a Biotech start-up that pioneered cannabinoid medicines. They have a broad range of experience - from running clinical trials themselves, to overseeing CROs, to building teams and all the process and systems that came along the way. They und
Matt and Steve have spent nearly 20 years working in Clinical Operations for GW Pharmaceuticals, a Biotech start-up that pioneered cannabinoid medicines. They have a broad range of experience - from running clinical trials themselves, to overseeing CROs, to building teams and all the process and systems that came along the way. They understand what it means to be starting the 'clinical trials journey', and how to ensure the best chance of success for your clinical operations.
Matt and Steve have led an Excellence in Clinical Operations (ECO) team and developed the 'ECO way of working' when it comes to setting up clinical operations and running clinical trials. Understanding what is needed to start clinical operations will help you and your team be even better. It is so important that you have the fundamental
Matt and Steve have led an Excellence in Clinical Operations (ECO) team and developed the 'ECO way of working' when it comes to setting up clinical operations and running clinical trials. Understanding what is needed to start clinical operations will help you and your team be even better. It is so important that you have the fundamentals done properly as we know from first-hand experience that things can change quickly and it's always best to have robust foundations to build upon.
Matt and Steve are very experienced when it comes to MHRA and FDA regulatory inspections. They have been part of numerous GCP inspections and know what it takes to ensure a successful outcome. These experiences have helped give them a unique understanding of the expectations required for a company at various points along its journey, le
Matt and Steve are very experienced when it comes to MHRA and FDA regulatory inspections. They have been part of numerous GCP inspections and know what it takes to ensure a successful outcome. These experiences have helped give them a unique understanding of the expectations required for a company at various points along its journey, leading to improved processes and systems with a pragmatic and sensible approach.
“Working with BlueGreen Clinical has been an incredible experience for Canurta. Matt and Steve's wealth of clinical operations knowledge, combined with their approachable and supportive nature, has truly made a difference. Their guidance has been instrumental in refining our SOPs, navigating vendor selection, and approaching regulatory inspections with confidence. Beyond their expertise, Matt and Steve have become like trusted friends, always ready to lend a hand. We're grateful for their genuine care and commitment to our success. Thank you, BlueGreen Clinical, for being an essential part of our journey.”
- Head of Operations, Canurta
“On behalf of the PsiClone Team, I’d like to thank both Matt and Steve at BlueGreen Clinical for our recent assignment. It was a pleasure working with you. The breadth and depth of your clinical operations experience and knowledge enables you to deliver a great service and product.
As an early-stage drug development company, PsiClone worked with BlueGreen Clinical to implement the foundations of our QMS and also the first building blocks of a GCP system in readiness for our future plans. We are very pleased with the delivery and quality of this assignment and would recommend BlueGreen Clinical to companies wanting to establish high quality GCP processes tuned specifically for their current stage of operations. We wish Matt and Steve all the best with their exciting new business and look forward to engaging with BlueGreen Clinical again in the future."
- COO, PsiClone Ltd.
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