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What to look for when outsourcing cardiac safety studies, including a compatible business mindset.
The cardiac safety market has expanded rapidly over the past few years. This expansion has been due to the regulatory concerns about drugs that cause QT interval prolongation. The recommendation for adoption by the ICH steering committee of the S7B and the E14 guidelines in May 2005 is further evidence that cardiac safety is now a major regulatory issue. As a result, there will be a substantial increase in the number of cardiac safety studies that need to be outsourced by biotechnology and pharmaceutical companies. In fact, the total number of ECG analyzed in 2005 by core ECG vendors was an estimated 2.5 million.
The increase in the number of ECG vendors together with the increase in the number of critical cardiac safety studies such as Phase I Thorough QT (TQT) studies means that the pharmaceutical and biotechnology companies' outsourcing decisions will be increasingly significant. The question of what criteria they use when selecting from a range of ECG vendors is pivotal to ensuring a successful study outcome.
Fourteen ECG Vendors were identified as commercial centralized ECG companies and were approached to provide information for the ECG Vendors Report 20051 : BioMedical Systems, CardiaBase, Cardio Analytics, Cardiocore, Covance Cardiac Safety Services, eResearchTechnology, Gentiae Clinical Research, Medifacts International, MDS Pharma Services, Nabios GmbH, Quantum Research Europe (now known as Hertford Cardiology), Quintiles ECG Services, Spacelabs Medical Data, and VIASYS Clinical Services. All of the ECG vendors were sent the same questionnaire.
The response rate from the CROs was an exceptionally high 93%, with only Quantum Research Europe declining to provide information. The report did not consider the Academic Research Organizations (AROs), which also provide core ECG services. The detailed questionnaire required the ECG Vendors to provide both qualitative and quantitative information. The qualitative information was collated based on the following criteria:
To quote from one of the ECG vendors within the report, "When sponsors are evaluating companies with similar capabilities, the decision can sometimes be based on intangibles." "Intangibles" in this context refers to the subjective nature of sponsors' decision-making process and could mean that a final decision is based on criteria outside the ECG vendors control (i.e., a bias toward a particular country or quality of office facilities). However, after assessing the qualitative information given by the vendors in the ECG Vendors Report 2005, much of the information presented will give the outsourcing sponsors a better understanding of the companies they are evaluating. However, care still needs to be taken when interpreting the data as the following example illustrates.
Figure 1 shows the direct clinical ECG experience in years for each ECG vendor within the sector. The graph shows that nearly 75% of the vendors claim more than 10 years experience. Furthermore, information not shown here but captured by the questionnaire revealed that nearly 60% of vendors claimed greater than 10 years of cardiology experience within the academic or university environment prior to becoming a commercial core ECG laboratory. All the companies claim to have acquired similar cardiology expertise either within the commercial or the academic environment prior to becoming a commercial business. This makes it difficult for the sponsors to use this criterion to differentiate between vendors, and it is therefore necessary to consider other data presented in the report, some of which are outlined below.
Figure 1. Company experience in years for each ECG vendor.
Understanding the senior management team is a key criterion and allows sponsors to truly assess and differentiate the vendors. The vendors with confidence in their senior management team or who had senior management support gave detailed information of their senior managers' careers, experience, and business vision, and emphasized the stability of the management team and their implications to the sponsor. To truly assess a vendor, it is essential that sponsors have a thorough understanding of the senior management team.
This criterion allows the sponsors to look at how each vendor manages and deploys their limited resources to help meet the expectations of the sector. In addition, it also provides the sponsor with an understanding of how vendors see their roles and those of their competitors. For example, one vendor took a strategic approach that involved developing their ECG services to specifically target Phase I cardiac safety studies.
It is essential to understand how the vendor companies manage their deployment of limited resources to meet strategic objectives, as this will be a good indication of whether the sponsors' own needs and concerns can be met.
Assessing the partnering solutions allows sponsors to understand how vendor companies work with external parties to improve their service offering. Successful partnering will have required the vendors to take a strategic decision on what benefits the partnership will bring (e.g., a technology partnership to ensure ECG equipment supply or a partnering to outsource ECG analysis to overcome projected capacity issues), how long they are entered into it, and what due diligence is required. Vendor companies that have implemented comprehensive strategic partnering solutions are more likely to have a greater understanding of sponsors' particular concerns and, more importantly, a flexible approach to delivering solutions using both their internal and external resources.
Outsourcing and clinical departments need to take a flexible approach when trying to differentiate between the core ECG laboratories. Although information from vendors regarding their ECG analysis methods, quality assurance, and how they can ensure on-time delivery of quality data is still an essential part of the outsourcing decision-making process, our preliminary observations suggest that by understanding their senior management team, business strategy, and partnering solutions, sponsors will make a soundly based, strategic selection decision rather than one based on "intangibles."
John Sulola* and David Harvey are directors with Macto Consulting Limited, The Lodge, The Long Road, Rowledge, Famham, Surrey GU10 4DL, United Kingdom, +44 (0) 207 731 8478, fax +44 (0) 1252 795325, email: john.sulola@MactoConsulting.comwww.MactoConsulting.com.
*To whom all correspondence should be addressed.
1. J. Sulola and D. Harvey, ECG Vendors Report 2005, Macto Consulting Limited.