Preclinical
Regulatory Affairs and Clinical Research Services l Clinical Regulatory Affairs and Clinical Research Services l Clinical
Trial Monitoring l Medical
Writing, Editing and/or Proofreading
Presentation:
Preparing and Presenting l Training l US
Regulatory Regulatory Affairs and Clinical Research Services l European
Regulatory Regulatory Affairs and Clinical Research Services
Overview
- Provide
long term project assistance or short-term advisory
- Act
as a direct extension of your Clinical Research and Regulatory
Affairs department, thus we can:
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- Serve
as your
full staff
- Augment your existing staff
- Fill
in for absences
- Cover
any emergency in work overload
- Provide
oversight
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- Tailored
Regulatory Affairs and Clinical Research Services:
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- Answer questions
by phone, email or fax
- Come
on-site for meetings and any necessary on-site development
and research efforts
- Meet
with third party vendors and suppliers on the clients
behalf
- Meet with
the FDA
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- Help
launch a project or product
- Develop
Post-Market Studies and Surveillances
- Set-up
Electronic Registries
- Manage Physician sponsored IDEs
- Expedite
clinical programs in a timely manner
- Analyze
situation in collaboration with your company’s
management
- Develop
or optimize strategic plans
- Navigate
through clinical challenges or compliance obstacles
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ClinReg Research, Inc. Regulatory Affairs and Clinical Research Services:
1.
Preclinical Studies
- Provide
strategic planning for product development and Pre-Clinical
Testing
- Assist
R&D
in regulatory strategy and regulatory work
- Write
animal study protocols
- Assist
in animal lab and conduct of animal studies
- Compile
and write animal study data to support and achieve next
phase of clinical research work
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2.
Pre-market and Post-market
- Write,
execute, and submit IDE/PMA's
- Assist
and guide in designing and conducting a clinical
trial
suited to your specific purpose
- Provide
strategic expertise and technologically advanced methods
for achieving
outcomes and efficiency
- Design Clinical
Trials
- Design,
write or review protocols (all
phases)
- Provide
study management (multi-site & world-wide studies)
- Provide Protocol
Management
- Ensure
compliance with the study protocol, appropriate SOPS and GCP
guidelines
- Conduct
Study Initiations
- Organize and run Investigator
Meetings
- Manage
Post-Market Studies and Surveillances
- Set-up Electronic
Registries
- Manage
physician
sponsored IDEs
- Strategize
and assist through reimbursement strategies
- Prepare
or update Report of Prior Investigations/Investigators
Brochures
- Design
or review case report forms
- Develop/review
Informed Consents
- Select Institutional
Review Boards (IRB)
- Submit
protocols for IRB review
- Recruit
Investigators and select
sites
- Coordinate
the many aspects of
conducting a study
- Monitor
studies
- Audit
Clinical Trials (Internally
or Externally)
- Assist
in conducting Physician Advisory Board meetings
- Help prepare
for FDA Advisory committee meetings
- Write FDA
audit report response
- Manage
Adverse
Events
- Maintain device
accountability
- Assist
in bring troublesome situations into compliance
- Train sites
for FDA inspections
- Develop/maintain
sponsor’s internal Study Project files
- Develop
Investigational Site Binders for Regulatory documentation
- Develop
and negotiate contracts
- Perform
literature search
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3.
Clinical Trial Monitoring
- Domestic
and International monitoring for all phases
- Available
in Multi Languages
- Write
Monitoring Plans
- Provide
comprehensive monitoring of Medical Device or Pharmaceutical
clinical trials for all study phases
- Conduct
center closeout
- Evaluate
data integrity
- Assist
in bringing troublesome centers into compliance
- Write Corrective
and Preventative Action Plans (CAPA) for monitoring findings
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4.
Medical Writing, Editing and/or Proofreading
- Animal
protocols
- Human protocols
- Annual
reports
- Final Reports
- "Positioning” statements
for regulatory strategies
- Abstracts
- IDE applications
- PMA applications
- Policies & Procedures
- Patient
Education Literature
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5.
Presentation: Preparing and Presenting
- FDA Negotiation
Meetings
- FDA
Presentations
- FDA
Panel Presentations
- Organize
and run Mock FDA Presentations
- PowerPoint
Presentations for variety of needs
- Physician
Panel Meetings
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6.
Training
- Product
training to physicians, site coordinators or field representatives
- Study
management training to in-house personnel site coordinators
or field
representatives
- IDE and
GCP training
- One-on-one
or group
- FDA audit
training
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7.
US Regulatory Regulatory Affairs and Clinical Research Services
- Provide
FDA regulatory strategy for device development and device
classification
- Act as
FDA liaison
- Submit
your study protocol to FDA for a Pre-IDE review
- Conduct
pre-submission meetings
- Work with
the FDA to resolve any issues with the study approach
- Provide
advice and assistance and acts as a direct or indirect liaison
between your company and FDA
- Assist
with clinical FDA negotiations meetings
- Assist
with device labeling requirements
- Provide
advice and support for preparation of 510(k), Investigational
Device Exemptions (IDE), and
Pre-market Approval (PMA) and
CE Mark submissions and post-market requirements
- Help or
prepare you for FDA Advisory Committee meetings or physician
advisory meetings
- Assist
with Import/Export
Issues
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8.
European Regulatory Regulatory Affairs and Clinical Research Services
- Review
strategic options for device development and market introduction
- Write clinical
trial and other regulatory submissions
- Assist with Import/Export
Issues
- Provide
advice
and hands-on support for European CE marking compliance strategies,
including:
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- Risk
Analysis and Essential Requirements
- Technical
Documentation
- Labeling
and Language Compliance
- Liaison
with Regulatory Agencies and Notified Bodies
- Clinical
Evaluation of Medical Devices
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