Flexible Outsourcing Models
Cost-Efficient Outsourcing Options for Medical Writing
If you’re looking to offload the burden of medical writing for your clinical trials, consider Quintiles your most proficient ally. Whether as a stand-alone service or part of a full-service relationship, we can fulfill your medical writing requirements across selected therapeutic areas or programs — or all of them. We adapt to your specific templates, style guides and procedures as if they are our own. We have formed successful ongoing relationships with numerous sponsors, some for more than five years. Here are two examples:
Comprehensive Writing Across All Programs
Working with a well-established, mid-sized pharmaceutical company since 2001, Quintiles has provided all medical writing services globally across all active research programs and a range of therapeutic areas. We have prepared protocols, informed consent templates and clinical study reports for well over 100 projects across Phases I-IV, as well as developed investigator brochures and CTD components for several compounds. The size and geographical reach of Quintiles have allowed considerable flexibility in resourcing this volume of work.
Overseeing our work together is a joint team comprising senior-level Quintiles writers and their counterparts within the sponsor company. This team meets regularly to discuss, examine and recommend process improvements and ensure consistency of approach. Decisions are then cascaded throughout the organization. Sponsor-specific training is given to all medical writers assigned to individual projects, with the regional representatives leading this to ensure that agreed practices are followed and consistent standards applied globally.
The sponsor benefits from ready access to a pool of medical writers experienced in using their preferred templates and processes and already familiar with the compounds and individuals involved — all of which help make the documents progress efficiently, smoothly and cost-effectively.
Focusing on a Single Therapeutic Area
A small, independent subsidiary of a global pharmaceutical company that is focused on one particular therapeutic area engaged Quintiles to write a single Phase I protocol in 2004. Our relationship has grown to encompass the majority of the Phase I–III clinical study reports for the key compound, both as stand-alone projects and in collaboration with other Quintiles services, leading to preparation of the clinical components of the CTD.
Strong relationship-building, good communication and continuity of key staff have been important factors in the success of this long-term relationship. As the relationship has grown, we have become an integral part of the customer’s project team and processes. Our growing knowledge of the compound, development plans, and the impact of study results on these plans — and even the individual preferences and styles of the customer’s team members — has really eased document development and approval.
All of these factors, together with the strong commitment of Quintiles’ staff, give any compound the best chance of a successful outcome.
