clinical trial patient support services at pii_aug 2016
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Clinical Trial Patient Support ServicesA Division of Paragon Meetings at Paragon International, Inc.
Kip Bourgeois, RN
Director - Clinical Trial Patient Support
August 2016
Clinical Trial Patient Support Services
Mission Statement
Provide clinical trial patients with the necessary
logistical non-clinical resources to support their
participation in clinical trial studies
We believe patients are the focal point of all clinical trials
Patient logistical support services continue to be
identified as an essential factor affecting participation in
clinical trials by: advocacy groups, patient support
groups, study site personnel (PI/SC/KOL/CTO); industry,
etc…
Clinical Trial Patient Support Services
What We Do
Provide full service non-clinical logistical
support for unique needs of clinical trial study
patients
Arrange and coordinate customized:
Transportation Arrangements
Lodging Support
Convenient Rapid Incidental Expense Reimbursement
Clinical Trial Patient Support Services
Resources Deployed
Leverage experience and expertise of Paragon Meeting’s successful
production of Pharma/Biotech IMs and events since 1995
Apply identical logistic services to patients that have been used to
meet needs of global travelers attending IMs and events
Implement Paragon Meeting’s established network to provide
logistic support to clinical trial patients via:
- American Express Global Business Travel Affiliate
- Paragon Staff Travel Agents
- Trial Specific Travel Managers
- Customized Travel Management
- Secure HIPPA Compliant Patient Travel Registration
Clinical Trial Patient Support Services
Travel Services Available
Air Transportation Commercial Carrier (American, United, Delta, etc.)
Air Charter
Air Ambulance
Ground Transportation – local, regional, national, and international Private Ground Transportation
Private Ambulance
Rail Reservations
LodgingHotel Reservations
Apartment Rental
Clinical Trial Patient Support Services
Patient Incidental Expense Management
Incidental Expense Reimbursements* may include:
Personal Vehicle Mileage
Private Vehicle Expense Reimbursement
Parking Fees
Baggage Fees
Taxi Fares
Meals
Miscellaneous Personal Expenses
*Charges can be recorded on Paragon Expense Reimbursement Form and submitted to Trial Sponsor for approval
or Sponsor may provide preapproved reimbursement schedule.
Clinical Trial Patient Support Services
Patient Incidental Expense Management
Electronic payments processed internally through
Paragon Treasury Management Platform
Payment method options include:
Checks in US dollars
Checks in other local currency
ACH Transfer
Wire Transfer
Paragon International MasterCard©
Clinical Trial Patient Support Services
Process
Step 1 - Analyze Clinical Trial Protocol
Provide both clinical and operational evaluation
Collaborate with Sponsor Project Management and
Trial Study Teams
Identify potential support needs based upon enrollment
requirements, patient population, duration of study,
treatment sided effects, schedule of events, etc…
Clinical Trial Patient Support Services
Step 2 - Assess Patient Support Needs
Assess for actual and potential patient support needs
from enrollment through to study completion
Address unique needs of each individual patient based
on condition, mobility, support systems, and needs of
dependents
Clinical Trial Patient Support Services
Step 3 - Study Site Training Introduce available services to study team
personnel - as early as Investigator Meeting
Provide individualized and group training to study
team personnel from study start up through to
completion
Utilize in person or WebEx training methods to
support study team personnel learning
Implement HIPAA compliant patient enrollment
system provided by Paragon
Support site capture and transmission of patient
data necessary to process travel arrangements
and manage participant expenses
Clinical Trial Patient Support Services
Step 4 – Enrollment / Evaluation Consult with each individual patient to determine their
particular needs based upon demographics, mobility,
support system, dependent needs, etc…
Confirm unique needs of each patient at each stage of
study participation where applicable
Implement mutually agreed upon plan with sponsor to
support enrollment needs
Reevaluate plan for any needed fine tuning where
necessary
Clinical Trial Patient Support Services
Expected Results
For Patients:
Validates vital role of patients as the focal point of a clinical trial
Lessens actual and perceived burdens of participation – for patients,
their support systems, and their dependents
Alleviates stressors of coping with logistical requirements needed in
order to commit to participation
Facilitates earlier enrollment upon meeting Inclusion / Exclusion
criteria at screening – resulting in earlier clinical intervention
Contributes to peace of mind for duration of study while ensuring
access to clinical trial resources – assessments, diagnostics,
treatments, etc..
Clinical Trial Patient Support Services
Expected Results
For Study Sites:
Increase access to patient population required by a protocol
Engage more effectively with “difficult to reach” protocol required
populations
Accelerate enrollment process upon confirmation of patients meeting
Inclusion / Exclusion criteria
Meet or exceed patient enrollment within sponsor required time frame
Eliminate need to arrange time consuming travel and logistical
solutions for patients
Increase time available to spend on clinical needs of patients and
protocol required study activities
Clinical Trial Patient Support Services
Expected Results
For Sponsor:
Achieve study patient randomization ahead of deadlines
Maintain patient enrollment estimates through to completion
Neutralize escalating costs re: startup, screening, enrollment, retention,
LTFU, voluntary withdrawal, rescue studies, etc…
Generate industry wide good will with patients and stakeholders
Leverage good will and efficiencies gained from patient focus approach
to realize projected study budget metrics
Validate vital role of study patients as focal point of trial
Empower patients to share positive experiences with family, friends,
and other patients who may be considering participation clinical trials
Clinical Trial Patient Support Services
Additional Information
Clinical Questions
Kip Bourgeois, RN
• 910-599-4430
Operations Questions
Dave Rock III
• 910-620-6520
Paragon International, Inc.
5725 Oleander Drive, Suite D4
Wilmington, NC 28403
T 888-429-5875 / F 910-772-1305
www.paragonmeetings.com