5 Qs with pH Associates

pH AssociatespH Associates is a healthcare consultancy who are recognised as the market leader in the design and implementation of projects to generate compelling real world evidence (RWE).

Real world evidence is central to the demonstration of value of healthcare innovation. In this growing and highly regulated area, pH Associates recognised the need to  utilise a data management system that meets compliance requirements while providing high quality, relevant and innovative data-driven solutions for clients.

Fran PercivalElsevier caught up with Fran Percival, Director of Quality at pH Associates to talk about their recent system migration to MACRO.

What were the challenges you were facing with your previous data management system?

FP: pH Associates manages data primarily for non-interventional studies. We recently acquired a new client who needed data management in a fully validated and compliant system, for non-interventional studies as well as for clinical trials.  So we started looking for the best system for us, for compliant data management for non-interventional studies.

How and why was the decision made to use MACRO for clinical data management?

FP: The factors we considered in our selection process were ease of data entry and trial design. There were three key areas where MACRO supported our needs. Firstly, we do a lot of retrospective studies so therefore needed a system that didn’t assume that we were doing prospective work (i.e. clinical trials). In this respect, MACRO gave us that flexibility and ease of study design. In addition to this, we work with clinicians within the NHS who are not necessarily researchers, so we required a system like MACRO that was easy for them to use. Finally, the fact that MACRO was web-based meant, in future, our NHS collaborators would not need to install the software onto their computers. This would help achieve buy-in from their IT departments and make subsequent roll-out easier.

A significant number of staff from pH Associates were involved in the decision-making process to use MACRO. We wanted to be sure that all the practical considerations of the people using it were taken into account.

How has migrating to MACRO benefited your clients?

FP: Our clients are generally pharmaceutical companies and having been able to say “Yes, we are compliant!” has removed a potential hurdle between us and them.  Recently, compliance of data management systems has become more important to some of our clients for non-interventional studies and so pH migrating to MACRO allows them to avoid having to give the data management to another provider. This is obviously preferable for them as it means they don’t have to manage two providers for one study..

What about the performance and productivity of those using the system?

FP: The project manager who started our first project on MACRO is a strong advocate of the product. She finds it very accessible, allowing continued use and the ability to fully collaborate whilst she is out in the field. That is an absolute plus. We’re also looking forward  to the benefits of being able to drag and drop forms that we have produced before into a new study.

Tell us which MACRO features you like the best.

FP: MACRO has been easy to use. There is ease in creating new variables and the ability to report on these variables in a number of different formats has also been very beneficial. Our analysts, who are the ones setting up the studies in MACRO, like that the language is intuitive * .

The best part about MACRO is the helpfulness of the people at the end of the telephone line. They are endlessly patient and very responsive, and we have really appreciated this whilst we are in the learning phase. We’re not left on our own after training. It’s a partnership!

For more information on MACRO, please contact Momen Hoque, MACRO Business Development Manager on 07801 254479 or m.hoque@elsevier.com.

* MACRO uses the technology of Arezzo that provides built-in capabilities for managing even the most complex study designs and edit checks without programming knowledge and with minimum validation effort.