WIC has designed medical device clinical trials across a wide variety of medical areas. Trial protocols are accepted by FDA the first round. Careful study planning leads to more effective and efficient trials.
- Protocol Development
- Case Report Forms
- Electronic Data Capture
- Informed Consent
- Patient Binder
- Study Budget
Protocol Document Development
WIC has developed numerous clinical investigational protocols (CIPs) in a wide variety of medical device area. WIC has helped several companies transform disapproved IDE studies into IDE-approved, high-quality studies.
WIC can provide you with a physician-ready CIP in both Word and Web-ready format, including pocket protocols on your mobile phone.
WIC helps device companies choose the best approach to statistical analysis. Trial success depends on choosing an endpoint that is both clinically relevant and winnable. Having the best statistical approach ensures this success.
Power and Sample Size
WIC has helped many clients determine study power (the chance that your study will be successful given the number of enrolled subjects) with simple but effective pre-trial modeling.
Often you do not know how effective your device will be. Performing an interim sample size calculation allows you to change trial sample size part-way through the trial, increasing the chance of study success. WIC has developed and successfully negotiated several adaptive trials with US FDA that specifically incorporate changes to total trial sample size at various points during enrollment. This approach ensures that your trial won't be too large or too small.
- As a result of predictive interim calculations, WIC helped Conceptus to submit its PMA study 3 months early to FDA.
- As a result of pre-planned interim calculations, Daniel helped Chestnut Medical Technologies to present early successful results to FDA.
Case Report Forms, Paper or Electronic
WIC has written numerous case report form sets for FDA-regulated and post-market clinical trials. WIC CRFs closely reflect the goals of the study protocol, including statistical endpoints, but avoid data collection burnout at sites.
WIC has rapidly implemented CRFs in an electronic data capture system (DataFax), which has been successfully used by several clients in pre- and post-market medical device clinical trials.
Electronic Data Capture
WIC has set up electronic data capture systems for many clinical trials. Through a joint agreement with DataFax, WIC can quickly set up EDC for your clinical trial. In contrast to large companies, set up can take just a few days.
Wild Iris can help you manage EDC, train users, and perform rapid data analysis from data collected via EDC.
Changes to CRFs can be required. In a recent EDC trial, WIC changed a CRF in 5 minutes!
Your trial sites need to obtain informed consent from potential study subjects with an informed consent form (ICF). ICFs must conform to national or international standards. However, clinical trial sites tend to have their own formats for ICFs, especially as they regard participation by pregnant women and radiation exposure. WIC has written and negotiated numerous ICFs with sites.
Patient Binder Material
Patient binders are hardcopy materials that serve as source documentation for patient care in clinical trials. WIC has written patient binders to facilitate data collection in clinical trials.
You have to pay sites for their participation in clinical trials. WIC can help you clinical trial financial forecasting.
Study Site Budgets
Each study site has a budget, usually on a per patient-visit basis. Site charges can be ephemeral. In many cases, WIC can reduce overall site start-up costs in both premarket and postmarket clinical trials.
Keeping track of which site was paid what when and for which patients can be a daunting task. WIC has developed web-based payment modules that can help you keep payment straight and well-documented.
Your study protocol and associated documents are written. Now it's time to introduce physicians and coordinators to it, and negotiate study start-up.
- Introduction to Physician
- Introduction to Coordinator
- Study-Specific Web Site
- Institutional Review Board
Introduction to Physician Investigator
You know which physicians you want to work with and have had introductory conversations with them. Now you need to train them on the details of your study. WIC has done web-based training of dozens of physicians on clinical trial requirements.
Once sites are selected, you need to train the study coordinator. WIC has trained coordinators on several studies via teleconference / WebEx.
At SI-BONE, WIC used SlideRocket videos that that allowed sites to train themselves. Your coordinators will already be knowledgeable in your clinical study before you initiate the site.
Obtaining signed documents from sites can be difficult and time-consuming. Why obtain printed signatures? Use electronic signature services to get sites to sign documents. These services are used worldwide by banks and law firms.
Once clinical sites are selected, you need to provide the site with substantial information. Email is a slow and inconvenient way of sharing information. WIC has created study-specific websites that can be used to share information, such as:
- Protocols and radiographic guidelines
- Case report forms and patient worksheets
- Regulatory documents
- Forms (training logs, financial disclosure, investigator agreements, etc.)
- Important web sites, clinicaltrials.gov listings
WIC has created study-related websites with the following functions:
- User and site management
- Site payment modules
- Site information trackers
- Study summaries
- Real-time enrollment stats
- Online subject-visit scheduling
- Training videos
- Online screening (embed screener into clinical site's own website)
- Announcements and HTML newsletters
- Frequently asked questions (FAQs)
- Study site maps
- CRF completion guidelines
Contact WIC if you need a study-related highly functional website.
WIC has successfully negotiated trials/consent forms with many IRBs and ECs, including tricky items like payment for injury clauses and payment for non-routine items.
Identify IRB Process
WIC can help you determine whether a local IRB or commercial IRB is required to get your study approved. WIC has interacted with commercial IRBs (e.g., Western IRB). WIC can help your site fit the informed consent form template into the site's own format and can answer medical and trial-related questions the IRB may raise.
Before your sites can enroll patients, you must have a signed legal agreement with the site. WIC has negotiated and reduced costs for clinical trial agreements with sites in the US and in Europe. WIC can keep costs low by identifying expensive items added by your sites that are not consistent with standard medical practices.
Sure, sites must be qualified to participate in your study. However, more importantly WIC can help you determine whether sites are excited about your study and will do the required work.
WIC can use your existing EDC system to create site management tools (e.g., qualification forms). At SI-BONE, WIC created online site qualification surveys to help screen sites for trial experience.
Physician and Coordinator Training
Physicians have limited time to undergo training. WIC can train physicians on-the-go using web-based technologies. Because Daniel is a physician, he understands how physicians think and how busy they are.
WIC has used advanced technologies to deliver study training videos to site coordinators. Coordinators viewing the presentations will be more familiar with your protocol and learn more during site initiation visits.
WIC has conducted numerous in-person clinical trial initiation visits, training trial sites in both US and Europe.
Your study is starting and is ongoing. You need to monitor your study and engage your sites.
Marketing Your Study
Engage your sites using styled HTML newsletters with your logo and design. Newsletters can be used to announce study milestones, welcome investigator and provide other relevant information.
WIC has used Google map services to create updatable study site maps showing name and location of your study sites. Since site information is stored in a database, the maps are updated on-the-fly.
Frequently Asked Questions
WIC has developed high-quality frequently asked questions pages. Page content is stored in XML, making it easy to update and share.
Implement discussion boards in your website to build rapport with your sites and to allow coordinators communicate with each other and with you.
Clinical Events Committee (CECs)
CECs adjudicate adverse events in some clinical trials. At Chestnut Medical, WIC successfully implemented a CEC for its pivotal trial. Since Daniel is a physician, he can challenge the CEC to ensure that their interpretations are medically consistent.
Data Safety Monitoring Board
DSMBs typically consist of 1-2 physicians and a statistician. WIC has written DSMB charters, run DSMB meetings and completed DSMB reports. WIC can produce interim statistical analysis that drives DSMB discussions. Since Daniel is a physician, he can challenge DSMB members who may not understand their role.
During and after study, you need data-based reporting.
Real-Time Online Reports
WIC has used scripting/SQL queries to query EDC systems to present real-time, web-based clinical trial reporting.
WIC can deliver customized SAS-based reports based on data snapshots.
WIC has substantial experience writing study reports. Because Daniel has statistical expertise, Daniel can both product statistical results (tables/charts/graphs) as well as describe the accurately using precise medical language. Daniel has successfully interacted with FDA on clinical trial study reports, answer questions with precise and reliable responses. Daniel understands statistical analysis and can go head-to-head with FDA statisticians.
WIC has attended and lead several FDA meetings. Daniel conducted a very successful FDA panel meeting for the Pipeline Embolization Device (Chestnut Medical, ev3).