1. Full-Service Collaborative Partnership Between a Pharmaceutical Company and a Vendor to Support Medical Information Services Amy L. Dixon, PharmD; Claudia Carlton, PharmD; Tamara Murry, PharmD ABSTRACT INTRODUCTION Reliance of drug development companies on outsourcing has risen sharply in the last decade. In 2001, such companies spent 14% of their drug development budgets on outsourced activities; by 2007, this expenditure had risen to 17%. Due to the increased outsourcing of clinical research and medical information activities, companies are continuously looking to increase vendor efficiency and performance. 1 Traditional outsourcing models focus on a transactional relationship, in which drug development companies outsource activities on an ad hoc, per project basis. Strategic relationships, on the other hand, relinquish the majority of a portfolio to a single vendor. This transition from project ownership to portfolio ownership allows the client company to increase internal efficiencies and focus on other functional areas. 1 As drug development companies increase use of strategic partnerships with vendors, these relationships will play an important role in helping companies improve performance efficiency. 1 Copyright, 2014 by Pharmaceutical Product Development, LLC ("PPD"). All rights reserved. This presentation, including the information contained herein and commentary associated herewith (“materials"), is provided as a service of PPD. These materials, based on publicly available information as well as the knowledge and experience of PPD's employees, have been prepared solely for informational and educational purposes, and should not be relied upon for professional advice. Any further use of these materials requires the express written consent of PPD. METHODS AND RESULTS OOS Activity Assessment: by Inquiry Source Objectives: To describe considerations for and the benefits of launching a full-service collaborative partnership between a pharmaceutical company (client) and a vendor’s global medical writing team. Methods: Objective and subjective client assessments of the partnership and related challenges and advantages will be evaluated. Preparations for the partnership and the process for reviewing work quality (for example, therapeutic area expertise, communication, and management) will also be documented. Results: This full-service, collaborative partnership involved the outsourcing of a large volume of United States and global medical information documents and activities. The client has expressed a high level of satisfaction with the relationship and the quality of the work performed by the vendor associates. 1. Getz K, Zuckerman R. Clinical research outsourcing: moving from transactional to strategic partnership-based outsourcing. Contract Pharma. 2008;10(5):66-71. FULL-SERVICE PARTNERSHIP: Multiple Products from Multiple Therapeutic Areas Global and US medical letters Literature searches Frequently asked questions Out-of-scope (OOS) inquiries Work gradually increased Endocrine, men’s health: Month 1 Oncology, 50% neuroscience: Month 2 100% neuroscience: Month 4 Technology Instant message, teleconference, softwareDaily communication, simplified oversight Product meetings Further client-vendor relationshipEnhance product/process training On-site training Foster positive relationshipsProduct/process training Key Steps: PILOT PHASE (MONTHS 1-6): Medical Writing Evaluation of Writing Deliverables During Pilot Phase Quality Monitoring: Assessment Measures Communication Project management TA/product expertise Quality Vendor oversight Extensive Appropriate PILOT PHASE : OOS Responses Affiliate survey: inquiries from HCPs outside the US assessed by regional global client colleagues Point-of-contact (POC) survey: inquiries from US-based HCPs assessed by US client contacts (20% random sample, Q2 only) Affiliate Survey Results POC Survey Results Knowledge/ Competence Comprehensive answer Clear and Understandable Ease of Requesting Info Relevant and Helpful 15 POST-PILOT PHASE Client’s increased capacity for work: Conferences and congresses Product launches Abstracts, posters, and manuscripts Regulatory and payor support Marketing/sales pieces Collaboration with global affiliates CONCLUSIONS A comparatively high level of vendor oversight existed in the initial stages. Decreased over time Ultimately yielded a thoroughly trained vendor staff The implementation of a full-service collaborative partnership has provided the client with: Increased capacity to perform other activities Medical information services of consistently high quality 14 Poor Excellent 13 SCALE Mean Assessment Values