Allow Clinsytes to focus on the clinical operation piece to ensure you get it right the first time while you focus on the science, and your investors. Executing the plan in a clinical trial can be complex. Lots of logistics and moving pieces so that you can hit your milestones, have great investigator relationships and ensure that your vendors are providing quality service on-time and on budget. Given that the sponsor is ultimately responsible for the project plan, safety to patients and the data, it is important that you do it right the first time. If you are a small biotech company and don’t have all the supports, Clinsytes can help you with some of the start-up processes to your clinical trial to ensure it is seamless.
This interim role can act as an interim clinical operations manager for a small biotechnology company while you are looking to internally hire the right fit ( this is hard to do and you shouldn’t just hire to fill a gap) or can be utilized as an extra set of hand if you have a small internal operations team. We all know that study start-up requires lots of time, work and oversight and it is important that milestones are hit. So we Clinsytes can fill this gap.
The benefit of the Clinsytes clinical consortium is that we have clinicians with over 20 years’ experience in clinical execution who will assist to review plans, look for any gaps, potential or current risks and suggestions on how to mitigate, with relation to your current clinical trial pathway as well as provide any of our services. Although, there is a collective group there is still only one communicator to you, your vendors, your sites but who always has a network in the background as an extra set of eyes but is seamless to you.
Conducting a clinical trial feasibility is both a science and an art. We know that >80% of trials fail to meet their original timelines, 37% of sites under enrol, 11% of sites never enrol …..this will increase or double your expenses if you choose the wrong sites. It is critical for sponsors to invest time up front in a strong feasibility process to ensure you time and money are not wasted later.
Our “Core-Feasibility Process” combines a scientific yet old fashioned common sense approach to finding the right investigators. Clinsytes, collate real metrics from investigational sites because we leverage a validated algorithm to find the right sites that provides highly responsive results from investigators and their teams. We have built trusted relationships by simply having conversations with investigators we know how to present the right information to engage and elicit the best responses for your trial
Choosing a Vendor or CRO for your program can be complex, subjective and daunting as it is critical that you hit your milestones and have positive outcomes. Understanding your Outsourcing needs is critical. The Clinsytes team will work with you to find the best vendors and suppliers that you need to execute a successful trial. Our team has worked on both sides of the business, so , we will provide the inside scoop and the tools to ensure you are choosing the right vendors which will save your money, keep your data and trial safe and manage your investigator relationships.