Clinical Research

  • Study Startup
  • Monitoring 
  • Trial Management
  • Project Management
  • Data Management

Ala Carte Clinical Trial Assistance

Consistency in staffing is imperative to the success of a Clinical Trial.  Study staff build relationships with sites, the study team, investigators, and collaborators.  Often this consistency can be broken as people take vacations, take parental leave, need to attend to sick relatives, or any myriad of reasons staff need time off to tend to their lives outside of work.

These breaks in staff consistency can be detrimental to trials for two main reasons.  The first one is obvious.  With staff away from work, deadlines may need to get pushed back, tasks may “fall through the cracks”, and sites become confused as to who they should contact with issues or questions.  Training new hires can often take months.  Filling gaps with highly experienced trial professionals through temp agencies is expensive, negatively impacting study budgets.

 

The second negative impact these breaks in staffing can have is when the departed staff return to work.  Often, they are thrown right back into the ring, but also have a ton of emails, phone messages, and other communications to catch up on.  This can quickly lead to the returning staff member feeling overwhelmed, frustrated, and unsupported.  Soon, your temporarily departed staff will be exploring new opportunities.

Flyover Clinical, LLC can solve many of these problems.  Our experiences in a diverse array of medical specialties, as well as our comfort with both drug and device studies, means we can “hit the ground running” and make immediate, positive contributions to your study’s success.  The reduction in time needed to get our team up to speed on a trial can help your team backfill temporary staff losses and keep your clinical trial on track.

Study Startup

Initiating a multi-site clinical trial and getting all the sites enrolling patients can be a monumental task.  We understand the pressures that sponsor teams are under, as well as the common hurdles encountered at different study sites.  We will work with your team to develop site-initiation plans that can efficiently start up sites, while also ensuring a short path to those important initial enrollments.

We can work with your study team in the following areas:

  • Budget Creation
  • Protocol Generation
  • Informed Consent Writing
  • Registration on clinicaltrials.gov
  • IRB Submissions
Monitoring & Proctoring
Our team has experience working as site coordinators and as clinical trial monitors.  These experiences have included on-site and remote monitoring, as well as coordinating for on-site and decentralized clinical trials. We strongly believe the relationship between monitors and study-sites should not be punitive or anxiety-inducing, but more collegial, friendly, and synergistic.  We can help you maintain the quality and integrity of your study data with the following services:

  • Remote and On-site Monitoring
  • Monitoring Plans and Reports
 
In addition to coordinating and monitoring, our team is also well-versed in surgical or procedural techniques.  We can provide remote or on-site proctoring for physicians working with new medical devices.  We can also work with our network of colleagues to arrange on-site, animal and human cadaver physician trainings.  
Trial Master File (TMF)

Clinical trials accumulate A LOT of documentation!  Organization of this documentation is paramount to ensuring the study and the sites are working from the most current documents, and that the study personnel all have current training, licenses, and financial disclosures.  Probably the greatest benefit of an organized Trial Master File (TMF) is to facilitate more efficient monitoring visits, audits, and study oversight.

Sponsor and/or CRO documentation, along with site files (ie. Investigator Site File or ISF) together make up the complete TMF.  The TMF is meant to “tell the story”.  Much like it would be hard to follow a story from a book missing pages, it is equally as difficult to follow a clinical trial with missing pages from the TMF.