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Functional sourcing is the contracted agreement to conduct specific individual job roles by an organization for another organization. The notion of functional sourcing has existed in several industries for years but was first introduced into the clinical research industry by clinical research organizations (CROs).
The concept of functional sourcing is to utilize a vendor to provide resources to perform the actual clinical research functions required as opposed to outsourcing the entire study. Under this model, the functions are performed by a CRO on sponsor systems by following sponsor processes. The sponsor retains control of the systems, data, standard operating procedures (SOPs), and project related oversight to the extent they desire and agree. The CRO provides the human resources, incurs the costs related to the team's employment, and is responsible for line management of the team.
This model benefits both the sponsor and the CRO. Because all the work is conducted by CRO resources on sponsors’ systems following sponsors’ SOPs, the sponsor benefits by maintaining control of service delivery without the burden of resource management and utilization. There is no risk of a sponsor not having access to the data. By utilizing sponsor systems, the sponsor controls access to the data.
The CRO benefits because the CRO has the opportunity to become a strategic partner with the sponsor and can, in turn, participate in the planning and forecasting process for sponsor resource needs. This is attractive to CROs because it is often difficult for CROs to otherwise manage fluctuating resource needs as various projects arise. Being involved at a higher level to understand sponsor needs helps the CRO manage resources. By the same token, this forecasting and planning methodology is something that the sponsor wants to outsource to the CRO.
For all intents and purposes, functional sourcing is really made up of a subset of outsourcing models:
Under the insourcing model, employees are on-boarded by the CRO, placed at sponsor or remote locations, and directed by the sponsor at their sites. Insourced resources are valuable in meeting research goals during periods of peak demand. This model allows sponsors to extend their current team without increasing their headcount. The task of the CRO is to then resource employees to the sponsor who can blend in with the culture of the sponsor company and provide the services that the sponsor needs in conjunction with the existing team. This prevents the sponsors from needing to bring on a dedicated staff when they do not have the long term need. Remote insourcing is similar to insourcing, except employees are placed at a remote location.
Under the employee transfer and re-engagement model, the sponsor transfers some of their existing employees to the CRO. The CRO in turn hires the resources as company employees and then dedicates them back to the sponsor. This allows the sponsor to offload the management of the employees and reduces their headcount but at the same time allows them to have the same individuals performing their services thus maintaining continuity across the project. The sponsor does not have to manage the resources over time but is still able to have the work completed by people they know and trust.
Outsourcing is where a sponsor turns over a task or service to a CRO. The service is performed on the sponsor's systems from a remote CRO office. This is one of the most common Functional Sourcing models.
One reason that functional sourcing is becoming a more widely used outsourcing model is the strides that technology has made in the last two decades regarding remote access. Today there are several ways in which remote access can be achieved. One method is to put in a dedicated hard line that connects the CROs machines to the sponsor's systems. Another way is for the sponsor to provide the CRO with a secure VPN connection that is made by connecting the firewall of the CRO to the firewall of the sponsor. Another commonly used method is where the sponsor treats the CRO like a remote employee by providing them their VPN software or a company issued laptop.
The benefits of all these methods for the sponsor are that all activities (including security) are driven by the sponsor. This allows the sponsor to grant and revoke access as they see fit.
One might think that functional sourcing is a US-based phenomenon and is not used frequently in other parts of the world due in part to physical distance as well as differences in culture, currency, and language. This, however, is untrue. The concept of low cost centers for Functional Sourcing is significant because it allows CROs to provide resources to sponsors around the clock. The idea is that resources can be located in different global locations but can still follow the same set of sponsor SOPs and can connect to the same sponsor network using the aforementioned techniques. The most considerable benefit to the sponsor is that functions can be resourced to regions of the world where the labor costs are significantly lower than the US. The cost savings to the sponsor in many cases may be as high as 60 percent of US costs. The benefit to the sponsor is obvious but this concept also benefits the CRO as it gives the CRO more versatility and allows the CRO to be more competitive.
Hybrid solutions include any situation where many outsourcing models are used in diverse and cross functional ways. Functional sourcing is an example of a hybrid solution. One of the benefits of hybrid solutions is that the models can be adjusted to meet the needs of the client. Multiple models can be used for different projects under the same sponsor.
For example, many US based companies that employ a Functionally Sourced outsourcing model are also implementing a low cost center model. As mentioned above, this allows US based CROs to augment their existing staff and maximize their resource availability. The sponsor, in turn, benefits from working with the senior management of onshore local partner while, again, taking advantage of lower costs and increased availability of the global resources.
This category is left for projects that do not fit into one of the previous categories. One of the advantages to functional sourcing is that it can be used broadly across the clinical research industry. Functional sourcing can be used for large projects as a way to alleviate resource management for the sponsor. It can also be used for global projects as a way to maximize availability and reduce costs. Additionally, it can be used by small companies who want to retain control of their data but lack the full-time resources. Finally, functional sourcing provides flexibility to the sponsor when they are in need of a flexible solution.
As mentioned above, the clinical trial industry has seen growth in functional sourcing over the last few years. This growth is tied to the continued adoption of functional sourcing in the industry. Having experienced success and gained significant confidence in the functional sourcing model, sponsors have decided to expand the use of this model to different areas.
In April 2009, Pharmaceutical Executive published the following regarding a major Pharmaceuticals company's use of functional sourcing: “… signals a profound shift in outsourcing practices. More and more drug companies—including Merck and Pfizer—are moving from "transactional" (capacity- and project-based) outsourcing to "functional" (competency- and portfolio-based) partnerships.” [1]
Sustainable management takes the concepts from sustainability and synthesizes them with the concepts of management. Sustainability has three branches: the environment, the needs of present and future generations, and the economy. Using these branches, it creates the ability of a system to thrive by maintaining economic viability and also nourishing the needs of the present and future generations by limiting resource depletion. From this definition, sustainable management has been created to be defined as the application of sustainable practices in the categories of businesses, agriculture, society, environment, and personal life by managing them in a way that will benefit current generations and future generations.
A software company is a company whose primary products are various forms of software, software technology, distribution, and software product development. They make up the software industry.
Outsourcing is an agreement in which one company hires another company to be responsible for a planned or existing activity that is or could be done internally, and sometimes involves transferring employees and assets from one firm to another.
Offshoring is the relocation of a business process from one country to another—typically an operational process, such as manufacturing, or supporting processes, such as accounting. Usually this refers to a company business, although state governments may also employ offshoring. More recently, technical and administrative services have been offshored.
Technical support is a service provided by companies to advise and assist registered users with issues concerning their technical products. Traditionally done on the phone, technical support can now be conducted online or through chat. At present, most large and mid-size companies have outsourced their tech support operations. Many companies provide discussion boards for users of their products to interact; such forums allow companies to reduce their support costs without losing the benefit of customer feedback.
Recruitment refers to the overall process of identifying, sourcing, screening, shortlisting, and interviewing candidates for jobs within an organization. Recruitment can also refer to the processes involved in choosing individuals for unpaid roles. Managers, human resource generalists and recruitment specialists may be tasked with carrying out recruitment, but in some cases public-sector employment, commercial recruitment agencies, or specialist search consultancies are used to undertake parts of the process. Internet-based technologies which support all aspects of recruitment have become widespread, including the use of artificial intelligence (AI).
Stages-of-growth model is a theoretical model for the growth of information technology (IT) in a business or similar organization. It was developed by Richard L. Nolan during the early 1970s, and with the final version of the model published by him in the Harvard Business Review in 1979.
Customised software is software that is specially developed for some specific organization or other user. As such, it can be contrasted with the use of software packages developed for the mass market, such as commercial off-the-shelf software, or existing free software.
Strategic sourcing is the process of developing channels of supply at the lowest total cost, not just the lowest purchase price. It expands upon traditional organisational purchasing activities to embrace all activities within the procurement cycle, from specification to receipt, payment for goods and services to sourcing production lines where the labor market would increase firms' ROI. Strategic sourcing processes aim for continuous improvement and re-evaluation of the purchasing activities of an organisation.
In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and Real world evidence.
Knowledge process outsourcing (KPO) describes the outsourcing of core information-related business activities which are competitively important or form an integral part of a company's value chain. KPO requires advanced analytical and technical skills as well as a high degree of specialist expertise.
Workforce management (WFM) is an institutional process that maximizes performance levels and competency for an organization. The process includes all the activities needed to maintain a productive workforce, such as field service management, human resource management, performance and training management, data collection, recruiting, budgeting, forecasting, scheduling and analytics.
One of the most dynamic and fastest growing sectors in the Philippines is the information technology–business process outsourcing (IT-BPO) industry. The industry is composed of eight sub-sectors, namely, knowledge process outsourcing and back offices, animation, call centers, software development, game development, engineering design, and medical transcription. The IT-BPO industry plays a major role in the country's growth and development.
Self-service is the practice of serving oneself, usually when making purchases. Aside from Automated Teller Machines, which are not limited to banks, and customer-operated supermarket check-out, labor-saving of which has been described as self-sourcing, there is the latter's subset, selfsourcing and a related pair: End-user development and End-user computing.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).
Software Testing Outsourcing is software testing carried out by an independent company or a group of people not directly involved in the process of software development.
Web access management (WAM) is a form of identity management that controls access to web resources, providing authentication management, policy-based authorizations, audit and reporting services (optional) and single sign-on convenience.
Cloud computing is the on-demand availability of computer system resources, especially data storage and computing power, without direct active management by the user. Large clouds often have functions distributed over multiple locations, each location being a data center. Cloud computing relies on sharing of resources to achieve coherence and typically using a "pay-as-you-go" model which can help in reducing capital expenses but may also lead to unexpected operating expenses for unaware users.
A human resources management system (HRMS) or Human Resources Information System (HRIS) or Human Capital Management (HCM) is a form of Human Resources (HR) software that combines a number of systems and processes to ensure the easy management of human resources, business processes and data. Human resources software is used by businesses to combine a number of necessary HR functions, such as storing employee data, managing payroll, recruitment, benefits administration, time and attendance, employee performance management, and tracking competency and training records.
Absence management, also known as leave management, is a combination of employer policies, procedures, or programs designed to handle employee leaves of absence and minimize the impact of those absences on the employer. Absence management programs aim to maximize productivity by supporting an employee from initial absence through return-to-work and stay-at-work plans.