1. Richardson Consulting Services, LLC
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2. Objective
Richardson Consulting Services assists emerging
biopharmaceutical and clinical stage
development companies by providing
– Strategies for executing clinical development plans in
a consistent, efficient and cost‐effective manner
– Strategies for building successful Clinical Operations
infrastructure to support planned and ongoing
clinical trials
– Experienced clinical project managers and other
resources to oversee and manage clinical trials
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3. Project Team & Associates
• Average of 10 years in the biopharmaceutical industry in
management and leadership capacities
• Expertise in establishing & executing strategies for
successful program and project management
• Experienced in managing CROs, vendors, and
consultants
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4. Therapeutic Areas
Members of the team have extensive experience in
several therapeutic areas:
• CNS – Alzheimer’s, bipolar disorder, depression
(pediatric, adult, geriatric), anxiety
• Cardiovascular – hypertension, PAOD/IC
• GI ‐ C‐IBS, POBD/Post‐op Ileus, chronic constipation
• Infectious diseases – grade IV neutropenia/AIDS, multi‐
lobar pneumonia, CSSI
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5. Therapeutic Areas Cont’d.
• Oncology – breast, lung, and renal cell carcinoma,
melanoma, sarcoma
• Pain management ‐ Chronic pain, primary
dysmenorrhea, fibromyalgia
• Respiratory – asthma
• Other – smoking cessation
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6. Services
Clinical program and project management
• Budget and timelines development and management
• CRO, vendor, and site budget and contract negotiation
• CRO and vendor identification, selection and
management (U.S., and ex‐U.S.)
• Site identification, qualification, monitoring &
management
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7. Services Cont’d.
Clinical program and project management
• Develop patient recruitment strategies
• Investigator meeting planning*
*sub‐contracted services
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8. Services Cont’d.
Data Management
• Manage EDC & data management operations and
vendors
• Formulate timelines for the completion of all data
management activities
• CRF/eCRF and CRF/eCRF guidelines development
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9. Services Cont’d.
Data Management
• Provide recommendations and input into clinical
systems and data management tools
• Conduct on‐site audits of data management activities,
processes, hardware, and software
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10. Services Cont’d.
Other Services
• Medical Writing (protocols, clinical study reports‐CSRs,
safety narratives)
• Benefit/risk analysis, risk management and input into
drug safety and pharmacovigilance systems*
• SOP development and process mapping
• GCP & GLP Compliance audits*
*sub‐contracted services
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11. Services Cont’d.
Other Services
• Coordination of expert/KOL and Advisory Board
meetings
• Management & oversight of consultants
• Coordination of due diligence activities with potential
partners
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12. Benefits of Early Partnering with RCS
• Early & ongoing expert
Minimize
Quality/
input into clinical
Project
Compliance
Risks program design, timelines
& budgets
– Minimize project risks
Client
Satisfaction
– Maximize cost savings
– Maintain compliance
with
GCP/GLP/GMP/ICH
Maximize Cost
requirements
Savings
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13. Meeting Your Needs
Align project/program
•
needs with corporate Manufacturing
strategy
• Devise & employ the best Stats/DM/Prog CM & C
plans & tools for executing
strategies
• Assign the best RCS Project
management resources Lead
Regulatory &
Sites
– Collaborate with QA
multidisciplinary team
• Select the most appropriate Medical/
CROs & vendors TA/
CRO &
Sponsor
Vendors
• Streamline processes Prog. Mgmt.
– Develop SOPs/
working documents
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14. Outsourced Model with RCS
Oversight
Sponsor
RCS Project Lead Consultant
Vendor
DM/EDC CRO
Primary
(IVRS, Lab)
Lead
CRO Global Lead
Leads
DM CRO
Vendor Proj. Mgr.
CRO Proj. Mgrs.
Proj. Mgr.
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15. Successful Outsourced Model – C‐IBS
Program
Sponsor Assoc Dir.
Assist Director, Pt. Recruitment,
Sr. CTM & Clinical E‐Diary Vendor
Team IM Planner
Vendors Sponsor
CRO Lead
(IVRS, Lab, US) DM/Prog./Stats
Project Mgr
Leads Lead
CRO Proj. Mgrs. Vendor Proj. Mgrs
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16. Key Benefits of Partnering With RCS
• Effective & reliable partner
• Innovation & efficiency
• Accountability
• On‐time & quality deliverables
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