It is no secret that the presence and growth of the outsourcing industry in the pharmaceutical sector has increased both in size and scope significantly over the last decade.
There are many reasons why a pharmaceutical company may wish to look into outsourcing certain internal functions and typically there is no shortage of options, both in terms of supplier, and also the arrangement that is chosen, be it on shore, off shore, short term, long term and so on.
One area that is often overlooked is the critical importance of effective transition management. Most if not all outsourcing deals begin with an end goal, such as reduction in bottom line costs to the sponsor, as well as opportunities to allow internal growth in other parts of the business and access to resources provided by the outsourcing supplier etc.
Unfortunately the drive to reach this goal can easily overshadow an equally important part, which is managing the transition in such a way that productivity loss is minimised, key staff are retained, and knowledge transfer is smooth and effective.
In many cases the effectiveness of a transition plan can make the difference between a ‘good’ or ‘bad’ start to an outsourcing partnership, because it can have a massive impact on the Day 0 (the point where changes are initiated on the ground) to Day X (point where the partnership is considered to be operating normally) time phase.
Typically Companies expect an initial phase of disruption (on boarding), to affect both internal and vendor dynamics, followed by a more settled phase as staff on both sides establish the new working structure. This would hopefully be followed by a long term phase of growth or reduced costs or both (depending on the overall aim of the collaboration).
There are a number of key areas that we look for in Regulink to ensure our clients minimise disruption and internal difficulties and maximise the speed to goal. A transition plan can in part be designed in the early stages, depending predominantly on the clients existing set up.
The eventual choice of vendor will then determine the second part of the transition plan. Some of this work could be carried out by the vendor themselves if it is appropriate to do so, or could be shared by the sponsor or Regulink or both in cases. This is usually determined at time of vendor appointment and depends predominantly on some of the factors listed below. It is also possible a vendor may be chosen or shortlisted due to experience or benefits they can bring to the transition phase, thus reducing costs and disruption.
Factors considered critical to the effectiveness of a transition include:
At Regulink our key process is to address these areas early, ideally before and during initial discussions with potential vendors.
Three of the most critical areas we will address in more detail (marked with an *) as through working with clients, a lack of skill and due attention to these areas, client perception of the success of an outsourcing partnership can be greatly affected.
Loss of knowledge over the lifetime of an outsourcing partnership is a very real threat to many clients, and sadly can be seen as ‘inevitable’, however at Regulink we believe that this process can be mitigated with the right planning and tools in place.
We typically see three areas where loss of knowledge occurs as shown by the below diagram.
The risk is generally related to the type of work being outsourced, the duration of the partnership, and the planned internal changes as a result of the outsourcing contract.
Without proper planning, knowledge from the client company would typically flow from left to right, as the outsourcing partnership progresses. Especially if medium to high skilled work is being outsourced, resulting in a loss of control by the client.
This can then lead to increased dependence on the outsourced company, and may make decisions to move to alternative vendors for potential benefits, more difficult as knowledge has been lost to the incumbent vendor.
It is no surprise that clients working with outsourcing companies would typically have a expectation in mind of what that partnership would yield. The goal of this partnership can vary significantly depending entirely on the clients short, medium and long term business goals, and can encompass one or several specific aims.
One issue that many companies face however is problems measuring and evaluating the performance of an outsourcing partnership.
The reasons for this are not generally very straight forward but at Regulink we generally consider four factors:
The basic fact is that accurate measurement and evaluation of performance is only more recently gaining the development and validation time it needs. Even medium to large outsourcing suppliers may be significantly deficient of robust in house tools, or may be asked to develop these tools at the request of the client, with limited internal knowledge of the best way to do so.
At Regulink, our approach is client enablement and upskilling, as we believe client control (even if shared with the vendor) is a more balanced approach to measurement and evaluation of performance.
This would typically encompass the areas highlighted above in conjunction with client specific details (internal resources, budget etc.) as well as the specific set up of the partnership of the vendor, as there are many factors that can have a small or more significant impact on accurate benchmarking.
Very much related to performance benchmarking, metrics and forecasting is an area which, in our view, is undeveloped compared to the needs of our clients.
Metrics measurement and evaluation has been used for some years now, and has long been seen as a ‘benefit’ derived from outsourcing work, as a means of capturing a clear cost/effort picture, that can be more challenging for internal departments.
There are still challenges however, with many companies struggling to find a suitable balance between the metrics they collect at the impact on time to collect them.
Depending on the complexity of the outsourcing arrangement and the level of experience of both the client and the vendor, finding the right balance can be a struggle initially, with a lack of highly user friendly tools being available. It can often be an iterative process with key metrics fine tuned over time.
At Regulink our approach is to use our extensive experience in the field to ensure our clients start with a solid foundation for metrics collection and analysis as well as overall performance and forecasting. We do this through several methods:
Forecasting has only very recently started to receive the attention it needs within the field of regulatory affairs. It could be safe to assume that the reason for this is in part due to the highly variable nature of regulatory affairs projects.
Factors that can influence the time and also volume of work are many and varied, and can be unpredictable, as well as external influencers such as changing business priorities.
The diagram above highlights the complexity involved with delivering a meaningful way of measuring and tracking work forecasts. At Regulink our approach is twofold:
Our overall goal is to enable our clients to gain maximum control over the regulatory processes and environments. Accurate forecasting allows our clients to prepare for any likely peaks and troughs in resource/project work and adapt or take action as necessary.
Implementation of our full transition plan is part of our service in conjunction with the early planning stages. This ensures all key factors from both client and vendor(s) are fully taken into account.
If you would like to hear more about our transition planning service or how we might be able to work with you, then please do contact us.
If you wish to discuss this article or learn more about how Regulink can help you with outsourcing and transition, please reach out to us.
"*" indicates required fields
Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list. Although not an exhaustive list, the main areas of our expertise and services are shown below:
Regulink provides pharmacovigilance services tailored to support your business needs. Our UK-based in-house QPPV has extensive experience from working as an EU and UK QPPV, with demonstrated leadership and management of large PV projects and teams of PV officers. We understand that all projects and clients are unique, so as with Regulatory Affairs, we offer a fully flexible service and work closely throughout to ensure your requirements are always met. The main expertise and services provided are shown below:
Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.
Read our expert’s thoughts on industry news and regulatory topics.
Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.”
Regulink provides specialist consulting and support services in all areas of regulatory affairs, CMC, pharmacovigilance and project/ programme management to the life sciences industry. We have a broad team with relevant experience in the key sectors of this diverse industry.