CRO Services from Clinical Device Group -- Click for Help
Clinical trials are not designed by one person, they take a team. Consider the big-ticket items you need:
[1] Project Management,
[2] Investigator's Brochure or Report of Prior Investigations,
[3] Study documents,
[4] Pre-IDE meeting with FDA (optional but recommended),
[5] Approvals,
[6] Study conduct.
On average, a new clinical trial takes 6-9 months to initiate; as much as 75% of your clinical trial labor will be spent on study start-up. You'll need people from toxicology, regulatory, clinical research, manufacturing, marketing, and R&D to pull this all together.
Knowing that you'll need a team of people, it makes sense to choose a CRO with experience at its fingertips. CDG has a network of independent experts who work together as needed in order to complete your project efficiently - Clinical Device Group's Network Staff. Download our eBrochure to see how we are organized.
You must think like a project manager to successfully implement a clinical trial. Begin by working backwards: what are the indications for use and related claims (assertions of truth) about your device that marketing wants to make? Use these to develop the hypothoses, endpoints, and outcomes measures for the study. These critical parameters will dictate the size, duration, and resource requirements for the trial. From here we can build a Gantt chart and study budget.
A good clinical research quality system will identify who does what by when, provide template forms, and assure efficiency and effectiveness through top management endorsement. CDG has a fully customizable Clinical Research Quality System available for purchase.
The Clinical Trial Project Manager is the person who plans the study and provides forward motion to the clinical trial. Lynette Chiapperino, AAS is an excellent clinical trial project manager. She can help estimate time, cost, and human resources needed for a trial. She understands what's needed, how to work with investigative sites to get what's needed, and how to interface with Clients to make sure the right work is being done.
Investigational device safety is of primary consideration before any human exposure to a device. The animal biological safety tests and animal preclinical safety and performance experiments can be reviewed in the Investigator's Brochure or Report of Prior Investigations by device toxicologist Dr. Dan McLain. He will assure the data offer reasonable assurance of safety and that as many questions as possible from the IRB and FDA are anticipated and answered in advance.
The Investigator's Brochure or Report of Priors requires a review of the prior clinical experience with your type of device. The clinical experience review might be prepared by Dr. Cheryl Hayden. Dr. Hayden has prepared over thirty clinical evaluation reports on the performance of different kinds of medical devices. Although she has a broad range of expertise, her specialty is diagnostic devices and biomarkers.
Next comes deciding which indication(s) you should pursue. CDG suggest's "easy claims first" but our marketing specialist, Judi Bednarz, can help you phrase your indications and claims to get the best play in the marketplace with the least burdensome requirements from FDA. "Work with the words", says Judi. We often ask her to assist in investigative site recruitment. With her knowledge of how to find people who know things, she is ideal for finding investigators with unusual skill-sets or hard-to-find subjects.
Most Clients prefer to write their own protocol, and then let CDG's experts review them for completeness, logic, and administrative details. Dr. Gail Radcliffe, PhD, Dr. Hayden, or Ms. Chiapperino are excellent for this purpose. Our Network Staff will work closely with you, staying in frequent contact and integrating their work with yours as though they are part of your company. This close contact assures that you have management control of your project.
The protocol's sample size must be based on defensible estimates. Michelle Secic, MS or Dr. Robert Thiel, PhD will work with you to design a study that gets you the indications you need with the least number of subjects. "Work with the words" they agree. These experts know from experience: for example, measuring the time to heal a wound versus the number wounds healed at a given time will lead to very different sample sizes. When the draft is more mature, Michelle or Robert will provide a statistical plan for data analysis.
The project manager assigned to your project, be it Dr. Hayden, Dr. Radcliffe, or Ms. Chiapperino, will craft or review the other study documents to assure they are user friendly. Case report forms should follow the protocol exactly. The question format should walk the form-filler through the data gathering process and be foolproof for the data-enterer to use. Informed consent forms must contain required elements, describe the study objectively, and identify any study risks.
 
The number of pre-IDE meetings in FY 2007 increased to 484 "due primarily to increasing awareness of the existence and usefulness of the program", its positive effect on successful first-cycle IDE review, and value for posing other issues to FDA. CDG's regulatory experts Karen Bannick, MS, Kathleen Johnson, RN, or Dr. Gail Radcliffe, PhD can organize and facilitate a pre-IDE meeting for you. At this meeting we'll cross-check the study design against the proposed indications to be sure FDA is in agreement.
More complex products or those with new technologies often require a Data Safety Monitoring Board or Clinical Events Committee (or whatever--a rose is a rose) to adjudicate adverse events; i.e., make the final call as to whether an adverse event is device related or not. CDG's Steve Schurr, Esquire has the clinical, legal, and DSMB experience to manage this external board of independent experts.
Non-significant risk devices require IRB approval only. Sometimes the simple devices are harder for IRBs because they don't know how to handle them. CDG's Staff has lots of experience in educating IRBs up-front to help move non-significant risk protocols to IRB approval.
Significant risk devices require full IDEs be submitted to FDA. Dr. Patsy Trisler, PhD, Ms. Bannick, Ms. Johnson, Dr. Radcliffe, or Dr. Hayden can all work with you to help plan a regulatory strategy and craft an IDE for FDA review. These experts have decades of regulatory experience and a huge breadth of product experience to bring to the table.
Our Network Staff can manage the study to assure implementation, not just monitor the study to follow its progress. We'll make sure every report is written, every form completed, and every document filed.
Of course Dan, Cheryl, Judi, Gail, Karen, Lynette, Kathleen, Michelle, Steve, Patsy and Robert all have multiple talents and can pinch-hit for each other. CDG has many other talented independents in our Network Staff, too. So if one person is busy or another has experience you'd particularly like to tap into, we can always accomodate.
Contact me now at 773-489-5706 for a complimentary consultation. I will discuss your needs, suggest a course of action, and recommend how best to proceed with your project. --Nancy J Stark, Phd, President.
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Project Managers
Biological Safety
Investigator's Brochure or Report of Prior Investigations
IDE Approval 
Consultation