There is growing reliance on outsourcing by pharmaceutical and biotechnology companies with $142.2 billion projected spending for 2015 on global R&D and nearly $60 billion on contract preclinical and clinical services.^1,2  According to a survey conducted by Jefferies, more than half of R&D budgets are expected to be outsourced during 2015.² Sponsor companies are forming integrated alliances with their CRO partners in order to create greater efficiencies and productivity.  Recent studies, however, examining the effectiveness and performance of integrated relationships, offer mixed results about the impact and satisfaction with these relationships.^3,4 

A study conducted by the Avoca Group (2013) found that respondents from sponsor organizations reported less satisfaction than CRO respondents in a few key areas including relationship quality, communication, and meeting expectations.⁵ In addition, a sponsor-CRO collaboration study by Vantage Partners (2013) revealed a number of areas that contribute to sponsor-CRO relationships that are performing well below expectations in terms of cost, quality and efficiency.⁶ 

In a recent study of a working group of 12 major pharmaceutical companies examining services outsourced across outsourcing relationship models, Tufts CSDD found that across usage data from 43 Phase II and II studies, no CRO managed all functional areas of an individual phase II or III study.⁷ The results also indicated that sponsors vary the types of outsourcing models that they use inconsistently and on a study by study basis. In addition, there were only two statistically significant findings in an analyses of performance and quality variables: integrated alliances had a higher number of screen failure rates and lower frequencies of protocol amendments. The results also revealed that the culture of an organization can impact its approach to outsourcing as well as attitudes and perceptions about outsourcing practices.

Background and Methodology
Tufts CSDD recently conducted a research study to examine and identify critical elements of collaborative sponsor-CRO relationships and ways in which these partnerships can maximize efficiencies.  The research study comprised both in-depth interviews and a roundtable meeting to gather additional insights into optimizing collaboration effectiveness.  Interviews were conducted with senior-level pharmaceutical and biotechnology executives in alliance partnerships. The interviews focused on practices, systems and processes that have been put in place across partnerships and examined how organizations maximize the value of the expertise that both parties bring to these collaborations.

A roundtable meeting with 19 senior managers from 13 pharmaceutical, biotechnology, and one CRO reviewed the data gathered from the in-depth interviews and offered potential solutions to the challenges and issues that were presented.

Results: Interviews and Roundtable Discussion
Tufts CSDD conducted interviews with 19 company representatives involved with alliance partnerships across 15 pharmaceutical and biotechnology companies. Respondents held diverse roles and responsibilities ranging from department heads to senior vice presidents. In-depth interviews covered a range of topics including communication, issue escalation and resolution and partnership model structure and function including composition of governance and steering committees. In addition, interviews focused on resource management and planning, performance and metrics, approaches to innovation and ideal characteristics within partnerships.

Some key themes emerged from the interviews concerning sharing pipelines and future strategy, CRO contribution to innovation within clinical development, and overall trust within the partnership. A majority of those respondents interviewed across companies revealed that future strategy is typically discussed at the executive level (executive steering committee). Most indicated that they have high level reviews of their portfolio with their partners, but only four interviewees indicated that their partners assist with protocol design or feasibility.

Innovation was an area where pharmaceutical and biotechnology executives hoped to see improvement and to play a greater role in their partnerships in the future. Most of the innovation that was reported could be described as increased efficiencies or enhancements to productivity.

A few major themes also emerged during the Roundtable meeting.  One topic reflected the need to change hiring practices within companies in order to avoid duplication of roles across pharmaceutical companies and CROs. Oversight of studies could potentially be achieved with different skill sets including problem-solving and operational expertise rather than one-for-one matches of jobs at these companies. Given the expertise across partnerships, another critical area was the opportunity to collaborate on protocol design. Collaboration and early involvement would contribute to a single team vision.

Collaboration as a team effort was illustrated by one company’s effort to organize and conduct a global face to face meeting of the core study team within a partnership. This effort was seen as an effective strategy to begin setting expectations early and align objectives and goals of the team. Last, the theme of developing a shared vision or patient focus across the partnership included being able to reach a broader base of patients for trials through use of patient panels and other data-driven approaches including electronic medical records (EMR).

Trust
Respondents provided various definitions of trust which included the view that increased risk-sharing leads both partners to benefit from success; being aligned on goals and objectives is a key component of trust, and displaying transparency by both parties is critical. Other areas underlying trust were understanding expectations and clearly communicating expectations to the partner. 

The theme of trust was explored further through the conceptual framework of a trust equation developed within management consulting that can be applied to any commercial relationship.8 The trust equation as adapted to the pharmaceutical industry reflects the following components of an alliance partnership: credible expertise; consistent delivery and execution; ability to collaborate as one team; and a shared vision of having a clear patient focus.

Credible Expertise
Credible expertise was reflected by the group’s perception of being able to identify expertise (both core and non-core) within organizations and having leverage to change companies’ hiring practices. There was consensus that a more efficient model could be achieved by elimination of roles unnecessarily duplicated across a partnership. Creating a ‘single team’ through clear delineation of expertise required to design and execute programs of work could potentially be more productive.  The need to impact hiring plans within organizations was also noted to avoid creating costly duplicate roles.

The concept of job rotation across partnerships was discussed as a way to allow staff from each organization to spend time in their partner organizations. This activity would help staff understand the different cultures and challenges that emerge and help to create a ‘single team’ approach.

Consistent Delivery and Execution
The group discussed that consistent delivery and execution in a partnership can be achieved through consistent support of executive leadership across the organization as a means to drive both process changes and skill requirement changes. The group agreed that integrating medical and statistical functional teams from pharmaceutical companies (i.e. teams that are responsible for study design) into a partnership at the outset is critical. Typically, these specific functional areas may not be integrated nor viewed as necessary. As a result, staff at CROs become unable to influence protocol design and are often perceived as not having the expertise to assist in the design of studies. Partnership barriers to achieving a ‘single team’ mentality become pervasive. One proposed solution is for pharmaceutical and CRO partners to create a series of pilot studies where protocol design is carried out jointly to show the value of a combined approach. Additionally, participation from the role of the physicians at pharmaceutical companies, although viewed as challenging, would contribute to the development of a strong partnership.

Conflict between partners was seen through focus on achieving first patient in (FPI), rather than last patient out (LPO) as a milestone, as CROs tend to be seen as failing in their ability to deliver. The focus on FPI rather than spending an appropriate amount of time on upfront ‘joint planning’ potentially leads to downstream issues in recruitment which in turn can lead to  protocol amendments, the addition of ‘rescue’ sites and avoidable change orders. Joint planning to assess protocol complexity and its impact on site/patient recruitment rather than a ‘race to FPI’ can significantly reduce time and cost. One recommendation for CRO staff to be more assertive in challenging the feasibility of protocols to identify recruitment/execution challenges before studies are initiated was discussed. A true ‘one team’ partnership should enable this to happen.

Ability to Collaborate as One Team
The group also highlighted the sponsor and CRO teams’ ability to collaborate as one team through setting expectations as a first step.  In a few cases a formal multi-day partnership kick-off boot camp was held where all parties met to share and discuss objectives, and to get acquainted. Such meetings can be repeated at regular intervals (annually) as new team members join and address progress against objectives.

The group provided only one example where CROs could offer more innovative solutions. The example discussed CROs having the capability to access and utilize data from electronic medical records to improve the identification of sites and patients relevant to specific protocols. Introducing efficiencies to study execution was not viewed as being innovative by pharmaceutical partners, but rather a standard requirement by all CROs. Innovation targets were included in certain partnerships but were not effectively described or operationalized. The group discussed the need to make innovation targets a joint partnership objective rather than a sole deliverable from the CRO.

Sharing pipeline information was viewed by all as extremely important but in only a few cases was this done robustly on a regular basis. Similarly involving the CRO partner at the protocol development stage was seen as important but again this didn’t happen consistently in practice.

Shared Vision/Patient Focus
The group examined the role of the CRO in patient centric clinical trials. The focus of the discussion centered on the need to establish a shared definition of patient centricity and partners working together as a single team to achieve this shared vision.
One suggestion seen as a key competency for a CRO was bringing panels of patients (and caregivers) together to assess the operational feasibility of specific protocols. ‘Taking the trial to the patient,’ or reducing the burden for patients to participate in studies is key to trial success, and an important area for developing a successful partnership. Another area is improving approaches to identify the ‘right patients’ for a specific study (e.g. through improved upfront planning and the use of EMR data), and is seen as pivotal in addressing a lot of the issues that arise within current partnerships.

Conclusion
Some of the key recommendations that emerged from the interviews and roundtable meeting that contribute to efficient and productive partnerships were the creation of a single team approach where individuals from both sides were engaged early on and were given autonomy.  Examples involved creating a series of pilot studies where protocol design is carried out jointly by both parties and having a more formalized kick off meeting between partnering organizations over multiple days that involves upfront planning. The role of EMR data in upfront planning was also seen as a way for CROs to maximize value and being viewed as innovative. Support of executive leadership across the organization was viewed as critical as well as the need to impact hiring practices that can maximize and leverage expertise, and avoid costly duplicate roles. Last, having a shared vision that is patient centric and being aligned on goals and objectives are also factors that contribute to successful partnerships. 

References

1. Global R&D Spend by World’s Top 500 Pharma and Biotech Companies, 2006-2020. Evaluate Pharma, May 2015.
2. Kreger, J, Murphy, A, Fatta, R, Bacso, M. R&D Trends Driving the Outsourcing Industry to 2020:  A 2015 Assessment. Parexel Sourcebook 2015/2016.
3. Windley, D, Dodge, S. An analysis of industry trends driving growth in outsourcing: A 2014 Jefferies survey.  Parexel Sourcebook 2015/2106.
4. Kaitin KI, editor.  Outsourcing to maximize clinical trial operating efficiency.  Tufts Center for the Study of Drug Development R&D Management Report. 2013 Oct; 8(4).
5. 2013 Avoca Report. Sponsor and Provider Perceptions on Managing Clinical Development Risk. Executive Summary.
6. Hughes, J., Rayer E, Wadd J. Sponsor-CRO Collaboration Study. Vantage Partners LLC. May 2013.
7. Getz, KA, Lamberti MJ, Kaitin, KI.  Taking the pulse of strategic outsourcing relationships.  Clinical Therapeutics 2014; 36(10): 1349-1344.
8. Green, CH, Howe, AP. The Trusted Advisor Fieldbook: A Comprehensive Toolkit for Leading with Trust. John Wiley & Sons, Inc. 2012.