Rcsllc Corp Presentation.Ppt 10 Nov 08
Upcoming SlideShare
Loading in...5
×
 

Rcsllc Corp Presentation.Ppt 10 Nov 08

on

  • 1,691 views

 

Statistics

Views

Total Views
1,691
Views on SlideShare
1,685
Embed Views
6

Actions

Likes
1
Downloads
18
Comments
0

1 Embed 6

http://www.slideshare.net 6

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Rcsllc Corp Presentation.Ppt 10 Nov 08 Rcsllc Corp Presentation.Ppt 10 Nov 08 Presentation Transcript

  • Richardson Consulting Services, LLC 11/10/2008 1
  • 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
  • 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 View slide
  • 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 View slide
  • 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
  • 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
  • Services Cont’d. Clinical program and project management • Develop  patient recruitment strategies • Investigator meeting planning* *sub‐contracted services 11/10/2008 7
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Key Benefits of Partnering With RCS • Effective & reliable partner • Innovation & efficiency • Accountability • On‐time & quality deliverables 11/10/2008 16