Outsourcing Model to Improve Traceability and Reduce Costs

The most prevalent outsourcing strategy among drug development companies remains the use of different full service CROs. However, there is a growing trend to split the component services of a trial among two or more companies in order to minimize risk, obtain greater efficiencies and make considerable savings.

Using a variety of full service CROs to obtain the right therapeutic expertise and geographic locations can result in dispersed clinical data across a program of studies. An alternative, which is gaining increased popularity, is to continue using such CROs but to centralize the data with one specialized vendor for all studies related to a single product or compound. The benefit is standardized data formats, improved traceability, greater leverage of work from one study to the next, and most importantly, a significant reduction of costs.

One of the primary reasons for CRO market success has been the rise of the “strategic partnership model” – a long term relationship between a CRO and a Sponsor built on trust and quality results. However, this does not have to be with one large CRO.

Centralizing Clinical Data

The attraction of large full service CROs is their ability to handle global trials, but this attraction should really be limited to the breadth of their site recruitment and monitoring resource. The data management, statistics and medical writing of the trial can be neatly centralized by a specialist company who will have a strong interest in satisfying the client and ensuring consistency in data formats for cross analysis purposes.

Centralizing clinical data services in the early phases of drug development provides the following benefits:

  • One relationship to align objectives and ensure continuity of team members
  • Better integration of studies across all phases with common assessment methods
  • Uniform traceability of data
  • One set of biometric Standard Operating Procedures (SOPs)
  • Centralization of study metrics and study reports

If the same Project Manager, Lead Statistician and Lead Data Manager are involved from Phase I, they are able to ensure that the study protocol and Statistical Analysis Plan and Clinical Study Report are all fully in line with the study objectives.

Clinical Data Outsourcing Costs

  • With EDC, companies can save up to 40% in database setup costs on 2nd and subsequent studies
  • In terms of biostatistics, companies can save up to 40% on statistical programming costs for follow-on studies.