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Your Strategic Partner for Integrated Solutions 1 © 2015 Frestedt Incorporated. F04304
Your Strategic Partner for Integrated Solutions
1 © 2015 Frestedt Incorporated. F-‐043-‐04
Clinical Research
Prepare• Assess feasibility, review literature, and create
budgets, protocols and essential documents
Initiate• Train personnel, submit FDA & IRB
documents, register trials and adhereto timelines
Conduct• Monitor trials, manage site staff, collect data,
analyze and report relevant information
Close Out• Close site, compile documents and create
comprehensive reports2 © 2015 Frestedt Incorporated. F-‐043-‐04
Regulatory Affairs
Strategies• Create comprehensive strategies to approachany regulatory body
Submissions• Create documents, secure approvals and
prepare reportsNegotiations• Correspond with stakeholders using clear, transparent communication to ensure timely submissions to facilitate approvals and clearances
3 © 2015 Frestedt Incorporated. F-‐043-‐04
Quality Systems
Develop and Provide Training• Create/update quality manuals, SOPs, work instructions and forms
• Stay current with new/upcoming regulations and guidances and standards
Conduct Audits and Audit Support• Identify, establish and schedule visit• Complete audits and assess straining effectiveness
• Follow up until findings are resolvedRisk Management• Assess plan and risk remediation efforts, identify gaps and recommend improvements
4 © 2015 Frestedt Incorporated. F-‐043-‐04
The Frestedt Value Proposition
With a holistic, customized approach we provide clinical, regulatory and quality affairs expertise for the biotechnology, food, pharmaceutical and medical device industries.
We deliver the best value for • high-‐caliber, integrated services based on sound
practical experience• working as an extension of your current team
5 © 2015 Frestedt Incorporated. F-‐043-‐04
The Frestedt Difference
Our broad, specialized network of 70+ passionate, industry experts transcends traditional boundaries of:• clinical research investigations, • regulatory negotiations, and• quality improvement systems
6 © 2015 Frestedt Incorporated. F-‐043-‐04
Frestedt History
Founded Founded
FEB 2008
JAN2012
Multiple Catheter
Evaluations for Large
Global Client
Submitted multiple 510(k)s
AUG2014
JUN2014
Conducted multiple Clinical Risk/Benefit Analyses
JUL2014
Completed dozens of Clinical
Evaluation Reports
OCT2011
Quality Summit in Belgium to Align Client International Regulatory Departments
APR2012
Completed Audit of Data Center and QMS for Clinical Trial
Software Client
Assumed Leadership of MAPS Applied Research Center Clinical Trials
JAN 2011
OCT2008
Presented Results of
Diabetes Clinical Trial presented
at FENS
DEC2013
7 © 2015 Frestedt Incorporated. F-‐043-‐04
The Frestedt Difference
CROs
Independent Consultants
• Delegate Control• Varied Expertise• Large Projects• Changing Managers
• SCALABLE CONTROL• KNOWLEDGE NETWORKS
• STRATEGIC PROJECTS• PASSIONATE EXPERTS
• Single Resource• Narrow Techical Expertise• Small Projects• Inconsistent Availability
8 © 2015 Frestedt Incorporated. F-‐043-‐04
How Does Frestedt Meet Client’s Needs?
• Thousands of new products are brought to the marketplace every year
• Regulations, clinical requirementsand quality solutions change frequently
• Corporate teams sometimes need a little help
Frestedt’s experienced people negotiate this complex network to hasten the progress of your product towards its full potential
9 © 2015 Frestedt Incorporated. F-‐043-‐04
What Are Some Frestedt Strengths?
• Virtual or in-‐person collaboration• Flexible operations to address
unique needs• Extensive knowledge networks• Passionate experts dedicated to
producing high quality work• Staff with diverse backgrounds to
handle a variety of business needs• Large network of expert consultants to
fill every need
10 © 2015 Frestedt Incorporated. F-‐043-‐04
Why Call Frestedt?
• Staff with diverse backgrounds to handle a variety of business needs
• Large network of expert consultants to fill every need
• Expertise and flexibility to work efficiently, filling in where we are needed, integrating into current teams, and leaving when the job is done.
11 © 2015 Frestedt Incorporated. F-‐043-‐04
Frestedt Fun Facts
• CERS generated• Peer-‐reviewed articles published• Random-‐controlled trials managed• Regulatory submissions and negotiations
completed (US, EU, Japan, Australia & Canada combined)
• Risk-‐based monitoring services and analyses provided
• Literature reviews conducted• Quality management documents developed
100’s100’s100’s100’s100’s100’s100’s100’s100’s100’s
Our experience includes 100+
12 © 2015 Frestedt Incorporated. F-‐043-‐04
Frestedt Clients
We work with some of the largest and smallest companies in the world and everything in between
© 2015 Frestedt Incorporated. F-‐043-‐0413
Case Study: Clinical Evaluation Report (CER)
SituationMid-‐sized medical device company required CER toremediate Notified Body findings
Frestedt Approach• Reviewed documentation and conductedsystematic literature searches
• Integrated findings and trained in-‐house staff to createsuitable reports and templates
• Managed client costs by allocating appropriate expert’s resources for at each level of the CER development process
Results CER completed and staff members trained. Notified Body cleared CER without further remediation. Working relationship established with Frestedt to conduct several other projects in client’s clinical, quality and regulatory departments.
14 © 2015 Frestedt Incorporated. F-‐043-‐04
Case Study: Regulatory Submissions
SituationStart-‐up pharmaceutical company needed regulatory to bring a drug to market.
Frestedt Approach• Formulated and negotiated generic drug regulatory strategy for
505(b)(2) submission • Devised novel combination regulatory product plan to limit testing
for kitted products• Obtained data from competing companies manufacturing the same
drug/device combination product• Updated and trained in-‐house staff on quality system improvements,
including new device testing requirements • Marketed a new convenience kit
Results Frestedt provided both in-‐house and virtual regulatory support/strategy to successfully bring generic drug and convenience kits to market — one of the first product approvals for a combination drug/device manufactured by competing companies.
15 © 2015 Frestedt Incorporated. F-‐043-‐04
Case Study: Two Special 510(k)s
Situation Hospital supply company needed a non-‐sterile version ofapproved sterile devices, but lacked medical device experience.
Frestedt Approach• Set regulatory strategy• Worked with the company to update design records• Created essential labeling • Assisted with packaging changes and testing• Avoided costly technical changes to device• Performed risk analyses on changes made • Recommended strategies to complete development and
launch ahead of schedule
Results: Frestedt submitted special 510(k) to FDA ahead of deadline, and secured clearance(without questions) for highest priority products. Also, trained company’s newly hired regulatorystaff and device design teams to meet regulatory requirements.
16 © 2015 Frestedt Incorporated. F-‐043-‐04
Client Testimonials
“Really like the depth of knowledge, organizationand ability to understand clients’ projects.”
“Great expertise in the area, good to work with,quick turnaround, someone you can trust”
“Frestedt was on time and within the targetbudget. Easy to work with”
“Thank you for all you’ve done. We heard backtoday that [our product] passed the audit. I amsure that the CER your team generated for ussignificantly contributed to that success”
17 © 2015 Frestedt Incorporated. F-‐043-‐04
Contact
Frestedt IncorporatedTel: 952-‐426-‐1747Fax: 952-‐426-‐1757
[email protected] www.frestedt.com
9445 Minnetonka BoulevardSt. Louis Park, MN 55426 Our clients say we are their
“first call for help”!
18 © 2015 Frestedt Incorporated. F-‐043-‐04
