Richardson Consulting Services, LLC




                        11/10/2008   1
Objective

Richardson Consulting Services assists emerging 
  biopharmaceutical and clinical stage 
  development companie...
Project Team & Associates

• Average of 10 years in the biopharmaceutical industry in  
  management and leadership capaci...
Therapeutic Areas
Members of the team have extensive experience in
several therapeutic areas:
• CNS – Alzheimer’s, bipolar...
Therapeutic Areas Cont’d.

• Oncology – breast, lung, and renal cell carcinoma, 
  melanoma, sarcoma

• Pain management ‐ ...
Services
Clinical program and project management

• Budget and timelines development and management

• CRO, vendor, and si...
Services Cont’d.

Clinical program and project management


• Develop  patient recruitment strategies

• Investigator meet...
Services Cont’d.

Data Management 

• Manage EDC & data management operations and 
  vendors 

• Formulate timelines for t...
Services Cont’d.

Data Management

• Provide recommendations and input into clinical 
  systems and data management tools
...
Services Cont’d.
Other Services

• Medical Writing (protocols, clinical study reports‐CSRs, 
  safety narratives) 

• Bene...
Services Cont’d.
Other Services

• Coordination of expert/KOL and Advisory Board 
  meetings 

• Management & oversight of...
Benefits of Early Partnering with RCS

                                        • Early & ongoing expert 
                 ...
Meeting Your Needs
  Align project/program 
•
  needs with corporate                           Manufacturing
  strategy
• ...
Outsourced Model with RCS 
Oversight

                                       Sponsor




                      RCS Project...
Successful Outsourced Model – C‐IBS 
Program
                                      Sponsor Assoc Dir.



                 ...
Key Benefits of Partnering With RCS

• Effective & reliable partner

• Innovation & efficiency

• Accountability

• On‐tim...
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Rcsllc Corp Presentation.Ppt 10 Nov 08

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Rcsllc Corp Presentation.Ppt 10 Nov 08

  1. 1. Richardson Consulting Services, LLC 11/10/2008 1
  2. 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 11/10/2008 2
  3. 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 11/10/2008 3
  4. 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 11/10/2008 4
  5. 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 11/10/2008 5
  6. 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 11/10/2008 6
  7. 7. Services Cont’d. Clinical program and project management • Develop  patient recruitment strategies • Investigator meeting planning* *sub‐contracted services 11/10/2008 7
  8. 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  11/10/2008 8
  9. 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 11/10/2008 9
  10. 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 11/10/2008 10
  11. 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 11/10/2008 11
  12. 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 11/10/2008 12
  13. 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 11/10/2008 13
  14. 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. 11/10/2008 14
  15. 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 11/10/2008 15
  16. 16. Key Benefits of Partnering With RCS • Effective & reliable partner • Innovation & efficiency • Accountability • On‐time & quality deliverables 11/10/2008 16

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