Traditionally, the staffing needs of most of the industry players are met through placement or recruitment agencies. But they have their limitations in providing appropriate qualified and experienced professionals for the upcoming new industries, such as contract research in biopharmaceuticals, as these resources are scarce. Hence, these players depend on the specialised resource providers which provides scientific resources on a temporary or full-time basis to a broad spectrum of industries, including biotechnology, medical / clinical and pharmaceutical. The other option for managing human resources requirements is to approach preferred service providers, perhaps CROs or SMOs, to provide contract staff on a temporary or permanent basis.

Although it is a lucrative business in world terms, this contract staffing model is considered to be new in terms of Indian clinical research. Many CROs have well structured contract staffing departments, which provide temporary and permanent staff to pharma companies. Major Indian pharma companies such as Pfizer, Roche, Novartis and Wyeth have already adopted this model in their clinical trial and biometrics business. After a thorough analysis and prioritisation, they are deciding as to which operations can be kept in-house, and which operations can be outsourced to the best service providers.

Mostly they are outsourcing their registration and post marketing surveillance studies to a local full service provider or a CRO and managing all the pivotal studies either by themselves or through contract staffing arrangements. Today, Pfizer has a contract staffing arrangement with ClinInvent, a local CRO, where ClinInvent acts as a functional service provider for them and provides contract staff at different levels starting from clinical research associates to study managers. Similarly, for biometrics, Cognisant and SIRO are working on similar models with Pfizer for data management and statistical analysis functions. Although today, there are a few players, who are exploring this model; it is unlikely be too long before this arrangement will also start to look attractive to other multinationals.

Advantages

In order for it to operate effectively, there is a constant need for the biopharmaceutical Industry to be on the lookout for talented staff. They seek talent by way of qualification, experience, a positive attitude and effective communication skills, so that they will be effective enough to influence the overall performance and success of the company that they represent. Moreover, due to the incredible growth in this Industry, the demand for well-qualified and experienced clinical staff is also at an all time high. These factors are responsible for the high attrition rate that this industry is facing.

Also contributing to the dilemma facing this industry is the fact that many companies need sufficient personnel available to meet project demands and eventualities and also work towards minimising long-term risks by keeping the staff head count low and in turn keep a tab on the overheads.

The CRO Industry has recognised this difficulty and has been working on various models to effectively assist the biopharmaceutical industry. One of these is to provide contract clinical research personnel to the industry as per their individual requirements. Contract staffing, also known as third party staffing, is still a novelty in India. It offers innumerable advantages to companies, which can then focus on their core competencies without having to bother about the practical details of managing a workforce.

This model offers client companies several advantages to:

n Have sufficient personnel at hand for their entire project related requirements and meet the peak time demand, without the need to recruit staff on permanent head count.
n Have access to experienced clinical research staff who are skilled in a variety of job functions which can eventually lead to reduced labour costs
n Reduce time spent in training the staff, and overall conduct of clinical trials,
n Improve quality of research through quality staff and supervision
n Retain control over their existing projects without the need to outsource the entire project.
n Provide a solution for the high attrition rate in this Industry. This method allows the sponsor to work jointly with the CRO to provide innovative incentives and support for quality staff retention. This service also guarantees a timely replacement in the face of attrition.
n Minimise long term risk
In due course, this trend should lead to a reduction in the cost of conducting clinical trials. CROs provide staff who are skilled in a variety of clinical job functions, and who can benefit client organisations by reducing labour costs, helping meet project deadlines, and responding to fluctuations in staffing needs.

Contract staffing services

There are different types of contract services, which have essentially emerged on the basis of the needs and requirements of biopharmaceutical sponsors.

Temporary contract staffing services make up the largest chunk of the staffing industry and these services provide sponsor companies with staff on a short-term basis, either to fill in for absent employees or to supplement existing staff during particularly busy times or perhaps for one-off services or for small duration assignments. It could range from few months jobs or a specific task to be completed in a short time. For example; 2 data entry operators needed to complete data entry work for 50 subjects in a week, 6 site audits for 12 days work of a QA auditor, or a therapeutic training to 5 CRAs for 3 hrs represent such scenarios.

Long-term contract staffing services, also essentially for long term clinical projects, where in trained and qualified staff are contracted for the duration of the trial. These services relate to staffing employees in long-term assignments until the completion of the project. For example, 2 CRAs are contracted for monitoring a 2 year duration study represents such a scenario.

Long-term to permanent contract staffing services are often combined with a long-term staffing service. This staffing service offers clients a chance to try out staff on a long-term assignment and gives the sponsor an option to hire a particular staff member on a permanent basis, subject to the consent of the contrac-ted individual.

There are very indistinct lines of difference in all these services and selection of a particular service is very much based on the need of the sponsor companies. In all the services, during the contracted period, the staff work as per the policy, procedures and norms of the sponsor, unless otherwise stated in the agreement. In each of these services, the contracted staff work on any one of the following models; Office based model: if the sponsor desires, the contracted staff shall work from their designated office or from the office of the vendor (CRO). This is of course is specified in the initial agreement and is budgeted appropriately.

Home based model: the contractual staff can operate from their home in different geographical regions to carry out the agreed task. In this model, the CRO and sponsor ensure that appropriate infrastructure is provided to the staff for them to carry out their functions properly. This bestows more responsibilities on the CRO to identify, recruit, train and provide appropriate staff in that geographical region according to agreed timelines.

Challenges

This business model poses numerous challenges to the service providers, especially in the emerging Indian industrial environment, where trained and experienced professionals are limited in numbers. The increase in the number of trials being outsourced to India may lead to sudden spurt in demand for experienced professionals by the pharmaceutical sponsors in different cross functional areas. If the contract staffing model is envisaged by the pharma companies as an alternate to the increase in head count, it would translate into considerable pressure on service providers to meet the timely demand for resources. The contract staffing service provider may have to invest heavily to train and build up a pool of resources, in order for them to be available to pharma sponsors in a timely manner.

This would also necessitate the service provider to create a detailed database of resources and implement a "well-oiled system" to identify, recruit and place resources as per the requirement of the sponsors. This system will help support the service providers to provide innovative solutions to the pharma sponsors to curb high attrition and provide replacements in case of such attrition.

Another area of concern for many pharmaceutical sponsors is to ensure that contract staff maintain confidentiality when dealing with their proprietary information. This is not anything new to a professional service provider as the entire CRO model is based on trust and contract. The service provider signs a confidentiality agreement on behalf of the contract staff to maintain confidentia-lity of their proprietary information. The secondment of contract staff to different pharmaceutical sponsors does not signify the end of responsibility for service providers rather it ensures through proper coaching, training and standard operating procedures that contract staff behave appropriately as per the expectations of the sponsor.

To remain competitive, service providers need to develop strategies to suit to the sponsors most pressing needs. If such approaches are centred on the sponsors' requirements and have a focused project-oriented management strategy, this enriches the long term relationship with the sponsor. To a layman, contract staffing and control by the sponsor appear to be opposite sides of a coin and look mutually exclusive. However, proper planning and thorough implementation of this model will yield better control with improved quality, timeliness and cost-effective output. Often, contract staffing services are misconstrued as that of placement agencies', although the approach is entirely different and involves a number of shared responsibilities. Yet sponsors should view this service model as a partnership building exercise of the service provider and promise to pay adequately for all the support. Thus the key to the approach involves looking at the mutual benefit.

(Umakanta Sahoo, MBA is general manager & Rakesh Lalchandani, is the business development executive (Integrated Resourcing) with Chiltern International Private Ltd, Mumbai)