Write Standard Programs Your People Will Use And Love!!

Standard program implementation is an interesting exercise that requires software development insight, good code design adapted to company existing standards and processes and also an implementation methodology that will facilitate their use and most important end-user’s adoption.

Although there is always a learning curve when using a new tool or program for the first time, it can be difficult to convince programmers to use a standard program if (they feel) they would have spent less time coding it themselves. Senior programmers often have their own undocumented and unvalidated although knowledgeful tool box that they develop and improve over the years and could probably do the job. There is nothing harder than selling programs to programmers and this is what standard programs are going up against in organisations.

This paper discusses different implementation strategies and important considerations that will increase programmers’ quick adoption and program release success. Industry standards implementation is reaching a certain state of maturity and many companies have engaged on the path of developing suite of standard programs to speed up the process of producing derived datasets and outputs but how to get the benefits quickly and keep work challenging and rewarding for staff in the long run?

At McDonalds ®, one of the most standardised companies in the world, the creativity is in the standardisation and development of associated processes. A Bigmac ® tastes the same in every restaurant in the world. Working in a McDonalds restaurant requires discipline, strength and some essential cooking and customer service skills. Clinical Programmers expect more from their daily tasks and the way we are approaching standardisation and its implementation at a larger scale will be crucial in retaining the talents in our industry.

Standard programs must speed up production of standard outputs so there is more time for the challenging and specific non-standard analyses. Make sure the programmers still get to program if you don’t want to loose them. Overall timelines are made assuming outputs comes fast with standard programs. If it doesn’t in practice because they are difficult to use or because they take too long to update, it means there will be even less time for the rest with obvious consequences on both quality and staff satisfaction.

This paper describes different implementation strategies and their pros and cons with respect to use of support organisations vs. clinical projects, internal vs. external resources and use of sequential vs. iterative models. There is no one-size-fits-all and concepts have to be adapted to company sizes, culture and outsourcing strategies.

Although the need for standardisation and development of standard programs becomes now obvious in our organisations, development of standard programs do not directly belong to the critical path of life-science companies where submissions or important trial milestones often drag resources at critical times. Organisations often struggle assigning and keeping resources for the time-consuming task of development of standard programs and adapt their structure and strategy to accommodate this process and their pipeline of clinical tasks.

A number of stakeholders are involved who do not limit to the only sphere of biostatistics. It is important to understand who they are and what are their needs and desires in order to shape the strategy and define adequate processes with respect to standard program development.