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International Clinical Trials

Data Driven

The pharmaceutical industry is under growing pressure from the complexities of the drug development process, hardening drug safety standards, increased regulatory scrutiny and the ongoing patent cliff. Indeed, it is estimated that $217 billion worth of originator products will have lost patent protection by 2018, with $150 billion of this amount predicted to be lost between 2010 and 2017 (1,2).

Leading innovators are constantly looking for new ways to pick up this shortfall – notably through emerging markets, which offer opportunities due to their spending power, potential for high volumes and offshoring capabilities. In addition, companies are looking to new strategies in the product lifecycle process to bring products to market faster. Better quality data and analyses are setting the stage for more rapid, informed decisions.

Given that only about 9% of all therapies will be approved in early clinical studies – with many being lost due to outdated and impractical trial designs (3) – this is an area in which significant improvements can be made in cost, quality and resources.

Outsourcing Model

Successful pharma companies are now thinking more strategically about their global business models, and over the last decade have increasingly turned to outsourcing to achieve their organisational and R&D goals. Business process organisations (BPOs), knowledge process organisations (KPOs), scientific process organisations (SPOs) and CROs have been integral in addressing the industry challenges through providing clinical development services, such as clinical operations, data management, pharmacovigilance, regulatory operations and statistical programming (4,5).

Statistical programming and analysis – or biometrics – requires a niche skill for service delivery. A globally distributed model for this activity has distinct advantages when it is effectively managed offshore. This article outlines the requirements and reasoning behind outsourcing this activity – particularly in emerging markets – and what is required to sustain and optimise it.

Statistical Activities


Inaccurate analysis and inappropriate study design can make or break a clinical trial, lead to wrong conclusions, and potentially result in significant cost and resource wastage. It is therefore essential to the success of the development programme to get the design and analysis of the trial correct.

Biostatistics and statistical programming now accounts for around 7% of total clinical trial costs, with the outsourcing of this function having risen by 20% during the past three years (6). The reason for this is growing internal costs, the requirement for computational and analytics capabilities, and the mature domain capabilities that BPOs, CROs, SPOs and KPOs can offer. Pharma companies that partner with service providers stand to gain up to 50% cost advantage through globally networked delivery (6).

Statistical activities are primarily performed in-house or through on-site or onshore consultants, due to the required level of skill and experience available in emerging markets. The small amount of offshoring for statistical activities that occurs is mainly limited to captive units that pharma firms have established in countries such as India and China. Only a handful of service providers have the required expertise and experience to deliver complex statistical services from emerging markets.

Clinical Programming

However, considerations for clinical programming are different. Due to the maturity the IT outsourcing industry had reached by the start of this century, pharma companies were keen to use the available infrastructure and resources to get their clinical trial programming work completed in a cost-effective manner through a globally distributed model. Clinical programming is still a highly resource-intensive activity, especially with the focus on validation and quality control checks at every step of the process. Offshore delivery teams can help to meet these demands through access to a large talent pool and by using the 'follow-the-sun' model – a type of global workflow in which tasks are passed daily between work sites that are across many time zones in order to reduce project duration and improve responsiveness.

While offering increasingly good infrastructure in emerging markets, BPOs, KPOs, SPOs and CROs can provide the niche skill sets and computational capabilities, together with better cost structures. Statistical programming is more challenging to deliver from an emerging geography than less complex work related to database programming, safety reporting or data mapping.

Selection of the outsourcing vendor should be largely guided by the complexity of the tasks being offshored. It is important to understand how the process should be sustained and optimised to successfully achieve the desired objectives.

Resource Balance


An initial consideration for pharma companies when offshoring programming work is maintaining a balanced mix of in-house and on-site resources versus offshore resources. Getting these numbers right during each phase of outsourcing is crucial. This will ensure there is enough in-house/on-site/onshore capacity available to provide mentoring and oversight as capability is being built within the offshore team, and also while productivity of the offshore team is ramping up.

Managing peaks and troughs, both in the onshore and the offshore requirement, is easier if contract resources are available at both locations. A good partner that can provide flex capacity offshore – instead of having only a captive team offshore and some contract resources onshore (in addition to a core in-house team) – will address this need.

Alongside this, it is also vital to consider the right kind of work to assign to the offshore group, and how it needs to change over time. Rather than allowing work to be sent through as it arrives, it is recommended that tasks assigned to the offshore group are carefully planned so as to gradually increase the complexity of their work, to match with the gradual build of the capability.

Ability and acceptance of the in-house and onshore teams to manage change should be continually monitored, especially with respect to changes in the type of work they do – for instance, providing more oversight and taking on strategic responsibilities, over being mostly focused on operational tasks.

Optimising Productivity

Productivity is an essential element of ensuring a streamlined, effective and efficient working system, and should not be overlooked when moving into new markets and working with international teams. There is a need to think beyond just ensuring the required levels of technical competence and functional expertise. Making sure desired levels of engagement and involvement within the offshore team are maintained, whether it is the captive group or a service provider, can make a real difference in this area. Various measures to achieve this – including on-site opportunities and involvement in end-to-end projects, rather than discrete and isolated tasks spread across several projects – should be considered.

In addition, there must be frequent communication with the offshore team, so that the distance and remoteness can be overcome as much as possible. Time zone differences can make constant communication more demanding, and it should always be top of mind.

The type of work assigned and the role on projects has to factor in the time difference to ensure optimal productivity. If used efficiently and correctly, time difference can also be worked to advantage and lead to enhanced productivity. The follow-the-sun model is well-accepted in today’s globalised environment, and has yielded clear benefits for many businesses. The same applies to the programming and analysis aspects of clinical trials, especially when there is a need to crunch the timelines for an interim analysis or a regulatory submission.

Sustaining Success

Once optimal productivity has been reached, sustaining productivity levels is top of a sponsor's and service provider's priorities. In order to ensure that productivity remains optimised, it is essential to define, measure and track metrics to monitor the success of the engagement.

With such evaluation procedures in place, along with mutually agreed targets, it is possible to gain a thorough understanding of the health of the engagement and recognise any problems before they become critical. While setting expectations and defining service-level agreements, it must be recognised that capability in emerging markets has to be built over a period of time.

Another aspect of sustaining productivity levels is hiring and developing the right staff within the teams. The average staff profile in emerging markets is often different from what companies may be used to in developed markets with mature drug development services. This group may have unique needs for professional growth and development. A continued focus on training will ensure all parties achieve the best possible results from the start.

Maintaining trained and productive workers is also important for managing volume fluctuations, and ensuring speed and quality. The demand-supply skew in emerging markets cannot be ignored. A certain level of attrition has to be assumed and there should be a strategy – such as a ready pool or buffer resources – to mitigate any risk to the business.

True Partnership


There are clear benefits to pharma companies that outsource clinical trial related statistical programming and analysis. By carefully employing an offshore strategy, improvements can be made in terms of availability of skilled resources, quality of analysis and adherence to timelines that will ultimately help companies make faster and more informed decisions at the right time.

Companies do, however, need to recognise that, while the emerging customer base and potential spending power is a huge incentive to those wishing to break into emerging markets, there are other considerations which should guide the decision to outsource these services. To optimise and sustain delivery, the key lies in selecting the right vendor and bringing in teams – remotely and onshore – that work well together in a cohesive manner to meet company objectives.

In can be a complex process to bring in external resources and then manage them effectively. This can be achieved by maintaining a balanced mix of resources, both onshore and offshore. It is essential that the importance of optimising and sustaining productivity is not underestimated once these teams are in place. Success will only come if the customer and the vendor work jointly in true partnership towards the common goal of continued effectiveness of the globally distributed model.

References
1. Insights into pharmaceuticals and medical products – Generating value in generics: Finding the next five years of growth, McKinsey & Company, May 2013
2. Global generic pharmaceutical market – Qualitative and quantitative analysis, Frost & Sullivan, presented at PharmaTech Conference 2013. Visit: www.slideshare.net/aiswariyachidambaram/pharma-tech-2013- aiswariya-chidambaram-fs
3. What is the probability of success of clinical trials?, Clinuity Blog, 2011. Visit: http://clinuity.com/blog/2011/02/what-is-the-probabilityof-success-of-clinical-trials
4. Outsourcing in the pharmaceutical industry: 2011 and beyond, KPMG, 2011. Visit: www.kpmg.com/ca/en/issuesandinsights/articlespublications/documents/outsourcing-pharmaceuticalindustry.pdf
5. Khan I, Competent statistical programmer: Need of business process outsourcing industry, Perspectives in Clinical Research 5(3): pp95-100, 2014
6. Sherlaker S et al, (P)re-scribing the innovation pathway, TATA Consultancy Services White Paper, 2013


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Chitra Lele is Chief Scientific Officer at Sciformix Corporation, with over 20 years of experience in the healthcare industry. She has been part of the company’s leadership from its inception, and instrumental in establishing and growing the organisation. Prior to Sciformix, Chitra was an Executive Director of Pfizer Global R&D, responsible for Indian operations. With a PhD in Statistics from Stanford University, her prior experience includes work as a biostatistician in cancer epidemiology at both Stanford and the University of California.
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