Where Are You in Your Clinical Trial Process?
Our clients prefer Bioclinica over other potential clinical trial partners because our experts provide insight and planning that stems from our past experiences. We’ve been there, so we can help you plan correctly and avoid the mistakes we’ve seen before. While other vendors may seek to expand your project to meet their budgetary goals, we recommend only the steps that will serve YOUR trial’s needs.
Pre-Study / Study Startup
Meet your First Patient In (FPI) date
When you are planning your clinical trial, many tasks are on the critical path to meeting your first key milestone: the First Patient In (FPI) date. You want to be able to get sites ready to enroll subjects quickly, so you’ll need a partner with experience in identifying, qualifying, and training the best sites.
Partner with Bioclinica and stay on the critical path to FPI:
- Developing protocols. We provide critical protocol guidance to make sure the imaging protocol is clearly defined for regulatory authorities and investigational sites before your trial begins. Bioclinica has extensive experience and the right experts to assist you with Special Protocol Assessments (SPAs).
- Identifying the right investigational sites. We’ve supported more investigational sites than any medical imaging provider in the world and are well positioned to advise you on the best ones to choose for your clinical trial. We know the investigational sites with the appropriate equipment and expertise to move your trial forward. If you need trusted sites in specific countries, with the highest quality and enrollment for a given indication, chances are we have some to recommend.
- Qualifying investigational sites. We ensure that they have the proper equipment and systems in place well before your planned Site Initiation Visit (SIV). We put everything in place for a smooth SIV and pave the way for Institutional Review Board (IRB) approval.
- Training investigational sites. Bioclinica is your partner to train investigational sites on imaging protocol and image submission procedures. We develop a user-friendly and comprehensive site imaging manual aligned to your protocol requirements and we make sure personnel are ready to hit the ground running. Depending on the complexity of the imaging protocol, Bioclinica performs training via an easy-to-use web-based system, virtual meetings, or in-person site visits.
- Maintaining relationships with investigational sites. When site personnel are informed and trained, they won’t need to turn to you for day-to-day questions, freeing you up to focus on the big picture.
- Reviewing patient eligibility. Bioclinica offers comprehensive image reviews of subjects’ planned enrollment date.
- Planning inventory logistics. Bioclinica’s forecasting tools allow you to avoid costly waste while making sure your investigational sites will have supplies of Investigational Product and placebo.
- Standardizing imaging quality. Our experts advise your team on which types of images to include in your protocol, and which to avoid. We develop a cohesive site imaging manual and image review charter via our medical writers, with guidance from our highly experienced radiologists and medical affairs specialists. We define quality from the start and ensure image quality across all investigational sites, so every image is evaluable, and data from every subject counts.
Get in touch with our experts about your clinical trial startup
Clinical Trial Phase I-IV / Ongoing Surveillance
Keep your clinical trial phases and timeline moving forward
Whether you are planning a Phase I, Phase II, or Phase III trial, or working on a Phase IV post-market approval or ongoing surveillance commitment data review, partnering with Bioclinica can help your program stay on track to inform your decisions and achieve your milestones.
Phase I/II
Phase II/III
Phase IV
Ongoing surveillance
How quickly can we get to the go/no-go decision on our therapy? Should we move forward, or find another indication?
Bioclinica has the expertise to streamline your early phases and get the data you need to make informed development decisions and attract potential investors.
How do we keep this process moving?
You need to keep your investigational sites running smoothly and producing usable data. Bioclinica manages even the most complicated global multicenter studies and basket trials.
How do we quickly gather and analyze data from our earlier phases?
You are over the hurdle of regulatory approval, but now you need to develop a synthetic control arm or perform a retrospective read of earlier images. Perhaps a Decentralized Trial design is being considered. Bioclinica has the people and resources in place to handle all your post-approval trial needs.
Commitments and the highest level of Pharmacovigilance support.
Study Closeout / Regulatory Review
Hit your database lock date
If you are nearing the Interim Analysis or closeout portion of your program, you need to meet that all-important database freeze or lock date and need experienced resources supporting your health authority Information Requests and pre-approval inspection activity, Bioclinica is your partner. This is when you need us the most and when you partner with Bioclinica, you can rest assured that we will provide timely, high quality closeout solutions that maximize data availability and results along with the most experienced team to support your regulatory needs. Your late-stage milestones are key to success and Bioclinica can help you to reach them.
Bioclinica helps reduce the burden and stresses of the final stages of your clinical program:
Speak with us to learn more about how Bioclinica can help with your study closeout
Rescue Study
Switch to a trusted partner to get your program back on track.
Is your clinical trial study or program facing roadblocks and on the road to nowhere? We know that the decision to switch clinical trial partners is a difficult and expensive one. Is your current vendor not helping you hit your milestones, introducing undue risk to your study, or not meeting your needs as a partner? Then it may be time to consider a change. Bioclinica has the experience and the resources to smoothly transition the clinical trial process with little disruption to your investigator sites, at any stage of your study.
| Problem | The Bioclinica Solution |
|---|---|
| My vendor can’t get our investigational sites up and running | We will work with your timelines to find qualified investigational sites and get them trained and equipped to hit your milestones. |
| My vendor doesn’t drive the timeline of my early study | Our proven systems allow you to have all the personnel, resources, and data you need to move forward. |
| My vendor doesn’t have experience in my study’s region/country | Bioclinica understands that customer service doesn’t work very well across multiple time zones. We have experienced project managers all over the world, so you get access to experts during YOUR workday. |
| Independent reviewers couldn’t read the images from my study | Our training and qualifying process means that all your trial imaging is of the highest quality. We use only US certified, highly trained technologists. They ensure the overall quality of images and minimize the risk of dropping valuable patient numbers from your analysis. |
| My vendor can’t handle a newly requested analysis | We are equipped to collect images quickly and perform a retrospective read for images you might not have anticipated at the planning stages of your trial. |
