CLINICALDEVICEGROUPCRO Capabilities from Clinical Device GroupA brief description of our services
It starts with a technology

You know your technology works, now it’s time for a clinical trial. CDG is here to help. We have a uniquebusiness model: all professional work is sub-contracted to our spider-web of expert Network Staff Associates. Click http://www.nancystark.com/CDG_eBrochure.pdf for an Acrobat pdf copy of our brochure andbusiness model.

Marketing needs determine indications for use

Meet Judi Bednarz
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 andclaims to get the best play in the marketplace with the least burdensome requirementsfrom 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 forfinding investigators with unusual skill-sets or hard-to-find subjects.

Biological Safety Assessments

Meet Dr. Dan McLain—Toxicologist
Investigational device safety is of primary consideration before any human exposure to adevice. The animal biological safety tests and animal preclinical safety and performanceexperiments can be reviewed in the Investigator’s Brochure or Report of Prior Investigations by device toxicologist Dr. Dan McLain. Dan’s PhD in toxicology, status as a convener
for ISO 10993-11, and years of experience in the medical device field give him high credentials for assessing the biocompatibility of a new technology or device, for preparing
expert reports to include in regulatory submissions, or in answering questions you havereceived from FDA.

Clinical Evaluation Reports, Investigator’s Brochures, Medical Writing

A Clinical Evaluation Report is a review of existing clinical and safety data to: a) determine there is alreadysufficient data to support your technology’s safety and performance for its intended use, or b) justify thedesign of a clinical trial. We have a team of medical writers and information specialists who can prepare
these essential reports for you.
Meet MEDIcept Inc—Medical Writers
F. David Rothkopf, founder and President of MEDIcept, has more than 20 years of professional strategic experience in the development, quality and regulatory control of medical devices. They offer engineering, quality, and regulatory consulting assistance to the medicaldevice and blood plasma industry. MEDIcept’s Todd Rhode and Joanne Fides have engineeringand quality system backgrounds that give them an edge in technical writing for high-technology devices.

Meet Dr. Charles Hurwitz—Medical Writer
American-born and educated, Dr. Charles Hurwitz has a PhD in Biology. He earns his living
as a medical writer, writing instruction manuals, manuscripts, and clinical evaluation reports. He has worked for several biotech companies and has prepared many 510(k) andCE submissions. Living in Israel gives him an advantage; he is closer to “Euro-think” thanmost Americans.
Meet Sunny Worel—Information Specialist
Sunny Worel was a former medical librarian. She has a background in Biochemistry and Microbiology (fromthe University of Minnesota). Sunny worked on the laboratory side of clinical trials and made immunodiagnostic kits before getting her Master in Library Science. She has been in independent information specialist
with skills in Embase, MedLine, and other biomedical searches for many years.
Meet Brian Hartman—Information Specialist
Mr Hartman holds a Masters Degree in Library Service, is proficient in Embase, MedLine and other biomedical database searches, and is highly comfortable in Access, Excel, HTML, and Visual Basic development. Hebrings a unique background in information management to his responsibilities as Information Specialist atCDG.

Regulatory professionals

Meet Kathleen Johnson—Pre-IDE meetings and regulatory strategies for devices
Kathleen has 12 years of experience in regulatory consulting. She is knowledgeable about
the requirements for all classes of devices and has submitted many 510(k)s for both ClassII and Class III devices, has experience with pre-IDE meetings and IDE submissions, andcan prepare Regulatory assessments for potential investor presentations. She also hasexperience with Quality System Manual preparation as well as Quality System Audits.

Meet Dr. Gail Radcliffe—Strategies for IVD start-ups
Gail loves a challenge and focuses her practice on new and interesting technologies. Her education in molecular biology and virology give her strong credentials for helping diagnostic
companies with complex new products. Gail has provided regulatory strategy for numerous
diagnostic and biological devices, assessed market opportunities for new technologies, developed business models (CLIA vs. FDA) for novel biomarker IVDs, and has helped investor anduniversity technical transfer offices determine the value of their IVD based intellectual property.
Meet Fabio De Pasquale
Living in British Columbia, Canada, Fabio De Pasquale has worked with several local and US
companies helping them to bring their devices to the US, Canadian and European markets.
His experience in quality assurance allows him to advise small companies on how to set upquality management systems. His expertise in regulatory affairs allows him to bring fresh
ideas to wording indications for use so that the best regulatory pathway is an option.

Meed MEDIcept Inc—Regulatory Engineers
In addition to medical writing, David Rothkopf’s group at MEDIcept is adept at developing
regulatory submissions such as IDEs, 510(k)s, PMAs, design controls, and quality systems for
CE certification. David’s group often audits existing quality systems to bring them into FDA
and ISO 13485-compliance. With his emphasis on engineering, I like to use David’s grouptechnology-intense projects.

Protocol development and study design

Meet Patsy Trisler
Patsy is one of those multi-talented people that can do anything regulatory or clinical. She islisted here under protocol development and study design, but could be listed under IDE approvals or regulatory submissions. To give you an idea of her breadth, here is a list of technologies for which she has provided strategic guidance: allograft tissue applications, bloodprocessing technology, dental products, drug delivery devices, dura substitutes, interventional cardiovascular therapies, orthopedics (including bone replacements/substitutes, bone

growth stimulators, growth factors & spinal technologies), pain therapy technologies, plastic & reconstructive cosmetic & rehabilitative products, soft-tissue reinforcement implants, software (medical), weight-loss
products, and wound care therapies.
Meet Cheryl Hayden
Dr. Hayden is educated as a microbiologist, has research experience in cancer epidemiology
and biostatistics, and has hands-on experience in clinical research. She has prepared overthirty 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.

Meet Barry Sands
Barry is a biomedical engineer with a chemical engineering concentration. He has sevenyears experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE
and FDA’s Boston District. This government experience was followed with seventeen (17)years in midlevel and executive regulatory/clinical/quality affairs management positions insmall start-up and large multinational medical device companies. His firm provides supportin the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers),
Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDAQSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).

Sample size calculations and statistical development plan

Meet Michelle Secic—biostastician
Michelle Secic, MS has worked on hundreds of protocols and the full range of devices, biologics, and drugs in her years as Manager of Statistical Analysis at Cleveland Clinic. She knowsa protocol’s sample size must be based on defensible estimates. She will work with you todesign a study that gets you the indications you need with the least number of subjects.
“Work with the words” she agrees. Michelle knows from experience that measuring the timeto heal a wound versus the number wounds healed at a given time will lead to very different
sample sizes. She will work with the performance estimates you provide to give you a tableof possible sample sizes.
Meet Dr. Robert Thiel—Bayesian and IVD specialist
Dr. Robert P. Thiel has degrees in physics and psychometrics. He is an expert in the analysisof IVD data for the Medical Device Industry with more than seventy-five 510K and five PMA
approvals. He has published papers in the areas of free PSA, breast cancer, ovarian cancer,
liver disease and multivariate analyses. His current interests lie in the area of bootstrap andpermutation test methodology and the application of these methods to small sample trials
and Bayesian analysis as applied to diagnostic clinical trials.
Project management
Meet Lynette Chiapperino—Monitor and Clinical Project Manager
The Clinical Trial Project Manager is the person who plans the study and provides forward
motion to the clinical trial. Lynette Chiapperino, AAS in medical technology and BS in management, is a born clinical trial project manager. She can estimate time, cost, and humanresources needed for a trial. She understands both the sponsor’s and investigator’s responsibilities and works both sides of the aisle when monitoring a study so that everyone’s
records are in order.

South of the border

Meet Patricia Hamilton—Regulatory, Monitor, and Project Manager
Patricia Hamilton is a Registered Nurse with a Master’s in International Business. She specializes in both domestic and international clinical trial management with a focus on SouthAmerica. She has DSMB and FDA experience. She has designed, implemented and completed pediatric device trials early and on budget. Her background as an emergency department nurse director and a clinical director for Fortune 100 companies give her theability to relate to physicians and nurses, understand hospital policies, and accomplish sponsor study
goals.

Case report forms and other study documents

Meet Dr. Nancy StarkDr. Stark has some pretty good skills with MS Visio and often works with the protocol designer, statistician, and data manager, to layout the case report forms. The goal is to makethe forms easy for the form-filler and easy for the data-enterer, while following the protocol
exactly. Three-part paper forms are still the best way to collect data for small studies or smallcompanies.

Study implementation
Meet Sue Lesly

Sue Lesly is educated with a BS in English and psychology, which explains her diverse
clinical research experience. She has been involved in all aspects of clinical trial performance including: monitoring, site recruitment, site management, CRA & CRO management, protocol development, CRF & source document design, development of study specific procedures & internal clinical SOPs, and preparing reports for FDA & regulatory
submissions.

Meet Kathleen and Lynette-monitors
Yes, these are the same Kathleen Johnson and Lynette Chiapperino you
met above. Multi-talented, Kathleen, Lynette, and Sue (above) are CDG’s
go-to people for day-to-day monitoring.

Data Safety Monitoring Boards and Clinical Events Committees

Meet Steven Schurr, Esquire
More complex products or those with new technologies often require a Data Safety Monitoring Board or Clinical Events Committee to adjudicate adverse events; i.e., make the final callas to whether an adverse event is device related or not. CDG’s Steve Schurr, Esquire has theclinical, legal, and DSMB experience to manage this external board of independent experts.

Data management

Meet Wessam Sonbol
Wessam Sonbol has a BS in computer science and business management, and he uses
these skills effectively to design databases to receive clinical data (Wessam is proficient inAccess, Excel, Clindex and other applications), validate the database, import data, andverify the data. He is comfortable with Part 11 controls and able to advise you as to how
and when controls should be implemented. Wessam has over 11 years of experience inClinical Data Management.

Reimbursement, comparative effectiveness, cost effectiveness

Meet Vincent Jaeger, MD
As you know, FDA clearance is the first hurdle, getting Medicare reimbursement or thirdparty coverage for your technology is the second hurdle. In addition to his practice as athoracic and cardiovascular surgeon, Dr. Vincent Jaeger brings to the table experience as
the National Medical Director for Coverage and Reimbursement at AETNA and then at
Health Net. This expertise gives him the background necessary to assist you in obtainig

third-party reimbursement for your technology or in designing reimbursement, comparative effectiveness,or cost effectiveness clinical studies.

We can help you; hire us as your CRO

Clinical Device Group has the capabilities to perform all of these tasks for you—we are a full-service CRO.
But if you prefer, hire us to perform specific tasks or act as an advisor to your staff.
Best Regards,Nancy J Stark, PhD
President, Clinical Device Group Inc
773-489-5721
cdginc@clinicaldevice.com