HOME SERVICES CAREERS HELP & QUESTIONS BLOG SIGN IN REGISTER The Latest Thinking in Strategic Resourcing Trio Clinical Resourcing Joins Forces with DOCS By Colin Stanley, President of DOCS As we continue to expand our services to provide strategic resourcing solutions that are flexible and tailored to meet our customer resourcing needs, DOCS is constantly looking for ways to grow our business and increase global coverage. I am therefore very pleased to announce that Trio Clinical Resourcing will become a fully integrated part of the DOCS business, as a result of ICON’s recent acquisition of Aptiv Solutions. This acquisition supports our ongoing plan to expand our global coverage, particularly in the US. Trio, a well-established resourcing provider, complements our existing business and aligns with our commitment to deliver excellence in insourcing and outsourcing services. Trio was founded in 2002 to meet the growing need for talent within the clinical trials industry. They have collaborated on more than 1,000 clinical trials across nearly every therapeutic area for a wide variety of customers including large pharmaceutical, small biotechnology, medical device, and in vitro diagnostics companies. In addition to servicing customers throughout North America, Europe, Latin America, Australia, and the Middle East, Trio boast a candidate network that is geographically rich and therapeutically diverse. With this integration, Trio brings a strong team of operational and therapeutic experts with in-depth understanding of resourcing needs in drug development. Further, Trio’s core competency of resourcing top talent, identifying, evaluating, and securing experienced professionals across multiple disciplines in clinical research supports DOCS’ goal to give our customers immediate access to proven resources to meet their project team needs. We are excited to welcome Trio to our organisation. Together, DOCS and Trio will lead the way in strategically resourcing the most effective and efficient clinical resourcing solutions. Keeping Functional Resourcing in APAC from becoming Dysfunctional By Paula Mumby Paula Mumby Business lore is filled with stories of how cultural faux pas have endangered or even derailed global projects. From my own position in Asia Pacific, I see first-hand the many ways that cultural differences can impact clinical trial planning and execution—particularly when functions are managed globally. What should you do when a Principle Investigator (PI) doesn't follow the protocol? How can you troubleshoot the reasons for low enrolment results? If your answers are formed with a Western bias, they are likely not the best ones for APAC. Testing the text and picture componentCRO’s working on behalf of sponsors need to be mindful of cultural nuances in the region to ensure that research projects run smoothly and deliver high-quality data. Without this deep local knowledge, expertise and respect a functional resourcing strategy—can easily become dysfunctional. Critical Success Factors – Across the board(er) All resourcing models from a single resource to FSP work best when partnerships between sponsors and CROs are in place, to clearly establish: Clarity of roles, responsibilities and risk-sharing parameters. Having clear accountability is particularly crucial when personnel operate in a matrix structure between the CRO and the sponsor. The potential for confusion regarding oversight responsibility is greater—and potentially more damaging—than in traditional, transaction-based outsourcing models. Detailed, program-specific escalation pathways. Personnel in both the CRO and sponsor companies must know how and where to address issues quickly. A multi-functional governance framework. Complex organisational structures, extensive communication networks and competing needs for information require a streamlined process for decision-making. Clear expectations on the responsibilities of local affiliates versus the global headquarters need to be established for both the sponsor and CRO. There must also be established communication channels. Workload and resource-forecasting mechanisms. Quality, business continuity, productivity and study objectives can only be met if the parties jointly create an accurate means of forecasting and retaining the resources required. A change management forum. Involving key team members in planning and implementing change facilitates a seamless transition as well as continuous improvement. Don’t get lost in translation Operating a functional resourcing model in APAC presents many of the same challenges as elsewhere, in addition to some specific to the region or to individual countries. The success of any strategic resourcing partnership in APAC will depend upon; the type of management support structure put in place, the degree of involvement by local affiliates, and the level of familiarity with local customs. Cultural differences and local conditions can manifest themselves in: Differing approaches to conflict management/issue escalation. In many Asian countries, people resist sharing "bad news," and managers must therefore stress that they want to learn of complications before they become "big problems." This barrier can be overcome by gradually building trust, by learning how to ask questions that elicit honest feedback, and by listening carefully to the responses. Cultural training and awareness of business practices can be useful for both local and overseas workers. The need for peer-to-peer interactions. In many countries, positions that are granted a high degree of status (such as PIs) should only be approached by positions of equal status. A Clinical Research Assistant (CRA) should not, for instance, be expected to give direction to a PI; rather, the job should be handled by a more senior executive. Staffing shortages. Significant growth in the region has created a shortage of experienced personnel, leading to salary escalation and high turnover. And this, in turn, is creating a training burden and rapid career progression. Resourcing programs must, therefore, include proactive hiring, retention strategies and ample training budgets for new entrants and new managers. Challenges to employees’ sense of belonging. In many APAC countries, employees feel a strong connection to their workplace, colleagues and managers. Consideration needs to be given to where employees are located and the sense of connection that they expect to have with their employer. Best practices for strengthening employee retention include thorough onboarding processes, recognition programs, investment in employees' training and career development and active communication programs. Discrepancies in salary grade structures. Accelerated career progression in APAC compared to the rest of the world can result in different experience levels for staff in the same function. This may necessitate salary and title adjustments. Given the expansion of clinical trials into APAC, success is becoming increasingly dependent on the extent to which cultural factors are addressed in functional resourcing arrangements. The best assurance that your business dealings will be sensitive to the local customs and cultural norms is to work with a local partner that has an established presence, a strong local network and proven processes for working in the culture. This will help to keep the “dys” away from the “functional”! Clinical Outsourcing Models: “Drive a Hybrid” By Colin Stanley, President of DOCS Colin Stanley, President of DOCS When we think “hybrid” we think of taking the best components from often opposing approaches and forming a new optimised solution. We think hybrid car; the hybrid cloud; maybe even a political coalition? This concept of combining the features or capabilities of two approaches has long been an effective strategy - the proverbial “best of both worlds.” When it comes to clinical outsourcing the biopharma industry has traditionally viewed full-service outsourcing and functional service provision (FSP) as binary options; where sponsors would select one or the other as their outsourcing solution. Yet, as the industry continues to evolve focusing ever more on cost efficiencies, enhanced performance and reduced time to market there is a need for more flexible outsourcing solutions. Enter “the hybrid outsourcing model” that challenges this paradigm, combining the strategic focus of a full-service model with the scalability of an FSP model, with a view to building custom solutions on a sponsor-specific basis. Know Your Options In full-service outsourcing, a sponsor relies on a CRO to handle all (or most of) the development project; from trial start up and execution, to accumulating and analysing the data, and finally to reporting on it. In recent years, companies have taken full-service outsourcing to the next level by developing strategic partnerships with CROs, such that both parties invest in the relationship with the understanding that it will be long term and value driven. In contrast, with FSP, the sponsor turns to a CRO to perform a key function across the sponsor’s portfolio of trials. The CRO may, for instance, provide resource and expertise in project management, clinical monitoring, data management, medical affairs, or statistics across the sponsors’ business. The systems and procedures employed may be either the sponsor’s or the CRO’s, but the sponsor typically manages the project and controls the trial technology. The CRO operates as a natural extension of the sponsor—its arms and legs, while the heart and mind reside within the sponsor organisation. A hybrid approach— aims to harmoniously marry these approaches, to create a more flexible, highly-customised solution for the sponsor. In this model, functional outsourcing fits within a partnership. The CRO is able to deliver economies of scale as well as the expertise borne of focusing on a specific function. The sponsor is able to take advantage of the CRO’s deep expertise, technology infrastructure and SOP’s while enjoying a high degree of transparency, control and flexibility in the process. Rule of thumb Selecting the best approach can be a challenge, and should involve a CRO having a deep understanding of the sponsors’ underlying development strategy and the scale of the work portfolio. These guidelines provide a useful starting point in the decision making process; Full-service outsourcing is preferable when a sponsor: Has a trusted CRO partner whom they rely on to be innovative, share in the decision making process and oversee quality drivers Needs access to expertise, technology and leadership in any of the clinical phases Is looking for an outcomes-based measures of success Functional service provision is the right choice when a sponsor: Wants to retain a degree of control over, and oversight into how a project is delivered Has access to, and wishes to retain internal expertise, systems and processes that are already in place Has variable workloads which require flexibility and scalability Is seeking improvements in quality and consistencies, while realising cost efficiencies A hybrid outsourcing model is appropriate when a sponsor: Requires a lean, resource-focused solution, which may include infrastructure and process input across multiple functions and/or regions in order to optimise gains Is looking to for significant reductions in oversight and cost, enabling them to pursue value-added, core activities Need the scalability, control, transparency, and flexibility of a functional model, coupled with the expertise, innovation, and SOPs in a full-service solution; supporting their expanding pipelines and improving efficiencies of development The Must Haves For a hybrid model to work well it must be custom designed to meet the sponsor’s unique needs. Critical to its success is a highly structured relationship guided by trust and communication. No two outsourcing solutions are exactly alike. Therefore, the CRO must remain flexible; capable of accommodating and supporting a variety of permutations in the working model. The CRO must have a proven background in FSP delivery and a solid, global infrastructure that can support the sponsor’s vision and evolving development needs. So, next time you’re thinking about “driving hybrid”, instead of thinking “vehicle” - you might just think about your clinical outsourcing models! For more information about outsourcing models at DOCS contact us Strategic Resourcing Partnership in APAC As we continue to see a growth in the number of clinical trials, there is increased pressure on sourcing and retaining skilled resources in APAC. Strategic Resourcing Partnership between providers such as DOCS and global pharmaceutical and biotech companies is one such of the solutions that can help overcome this challenge. Here is a short overview of strategic resourcing - what it looks like, trends and key considerations. September 2013 Life Science Leader Should Your Outsourcing Model Be Functional, Full-Service, Or A Hybrid FSP? Colin Stanley, President of DOCS outlines the different outsourcings options available to the Pharma Industry. Download PDF July 2013 Clinical Trials Insight Form and function combined Barry Balfe, Vice President of Global Program Management at DOCS, looks at the trend of using strategic functional service provider alliances to improve the challenges facing the pharma industry. Download PDF March-April 2013 Pharma Asia Strategic Resourcing Partnerships in Asia Pacific Paula Mumby, Vice President of Operations Asia Pacific, and Barry Balfe, Vice President of Global Program Management at DOCS, outline some of the key points that need to be considered when establishing functional resourcing and FSP partnerships in Asia Pacific. Download PDF December 2012 Clinical Trials Insight Functional pharma As the pharmaceutical industry continues to move away from transactional outsourcing, functional service provider solutions are growing in popularity. Barry Balfe, Vice President of Global Program Management at DOCS, explains how the DOCS FSP Delivery Platform can drive efficiencies across the clinical development spectrum. Download PDF News Events Jobs About DOCS Contact Us Investors DOCS E-learning Cookies Privacy Disclaimer Sitemap FOLLOW US ON LINKEDIN © 2013 DOCS. ALL RIGHTS RESERVED We use cookies on this website. 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