Talking R&D: Strategic vs full service CRO
pharmafile | September 1, 2010 | Feature | Research and Development | CRO, Talking Point, Talking R&D
CRF Health’s Greg Jewett and Medpace’s Alita Hassan debate the merits of a strategic or a full service contract research organisation.
Greg Jewett: Strategic vs full service CROs – which is better? As with most questions in the clinical trial world, the easy and often accurate answer is “well, it depends”.
When you’re talking about strategic (read: service specific) vs full service CRO usage, it often depends on the sponsor itself. Once the decision is made to outsource at all, there are a few more questions that need to be considered: Does the sponsor have the resources or desire to manage multiple service providers or just one? Does the sponsor feel they have the expertise to understand all of different service areas necessary to run the trial successfully? Does the sponsor have an experienced procurement team to handle the outsourcing process, evaluation and contracting with multiple service providers? Or even know which providers to begin to evaluate?
These days, it seems many sponsors like to take the approach of ‘one-stop shopping’ and allow the full service CROs to handle most of their outsourced needs. These needs could include any of the following resource functions – site monitoring, data management and project management are typically the lion’s share of outsourced resources. But statistics, programming, pharma-covigilance and medical writing are gaining in popularity for outsourcing, particularly for smaller to mid-sized sponsors. And there have been additional services outsourced lately – like feasibility and site recruitment, site startup and contracting, and patient recruitment – that were not even considered a few years ago. Theoretically, all of these could be done in-house by the sponsor but is sometimes easier to outsource even some of these core services. And there has also been the continued emergence of functional service provider (FSP) models, which are essentially staff augmentation outsourcing efforts, vertically within a single function.
These can range in size from a single-digit number of programmers to a pool of dozens of CRAs all the way up to hundreds of data analysts and managers. Most other clinical support requirements must be outsourced. The standard needs are central laboratories, central randomisation/IVRS and drug supply management. As studies themselves become more complex and more global, there will be added influence on the service providers within those spaces. Nowadays, there are some specialty services that are becoming increasingly necessary – like electronic patient reported outcomes (ePROs or eDiaries), central ECGs and medical imaging to just name a few.
So which CRO outsourcing method to use? There are benefits to both ways
When you employ a full service CRO model, the benefits to the sponsor typically are:
• One outsourcing process, negotiation and possibly one contract
• One point of contact throughout the project
• One (pardon the expression) ‘throat to choke’ when there are issues
• CRO may have more, broader experience with many specialty service areas and providers
• CRO may be able to incorporate data from multiple providers in single stream.
Challenges to the sponsor using a full service CRO model may be:
• CRO may not know all of the specialty service areas or best providers to utilise
• CRO may not employ a full evaluation of specialty service providers
• Limited visibility to specialty service providers
• Limited visibility to root cause of issues (potential finger-pointing between CRO and service providers)
• May not allow for true engagement with specialty service providers.
When you employ a strategic CRO model, the benefits to the sponsor typically are:
• Control over outsourcing process and service provider selection
• Ability to better understand their specialty service areas
• Ability to manage service providers individually
• Knowing the correct ‘throat to choke’ when there are issues
• Ability to build a relationship with specialty service providers.
Challenges to the sponsor using a strategic CRO model could be:
• Sponsor may not know all of the best specialty service providers to employ
• Quite a number of providers to engage from outsourcing standpoint
• Time and expertise to handle multiple service areas from outsourcing standpoint
• Experienced resources to understand and manage specialty service providers throughout project.
Due to tougher regulatory requirements and a greater emphasis on health outcomes and post-marketing surveillance, sponsors must find ways to increase their differentiation and better highlight the benefits of their drug. This may only be possible through more specialty services. It is safe to say that the average number of outsourced services in a typical clinical trial is increasing.
To a specialty service organisation, like an ePRO provider, it is critical that we do three things – first and foremost: develop sound technology, process and delivery – demonstrating high quality work to sponsors; secondly, build and develop broad and wide relationships with CROs and other service providers; and finally, ensure that your services are easy to understand, implement and support.
And since sponsors are likely to use multiple CROs for all of their trials, it is beneficial for them to best comprehend their specialty service needs and the expert organisations that provide those services.
There will always be the need for sponsors, big and small, to use a single CRO to fully outsource all of their study needs. But there also will be the need – and probably an increasing need – for sponsors to understand and trust all of the service providers that support their studies, particularly since at the end of the day, the study results are still the responsibility of the sponsor. So with either CRO outsourcing method employed, it is important to remember that when the database gets locked, the clinical study report gets finalised or the submission gets prepared for a regulatory agency review, it is the sponsor that needs to feel confident and comfortable that they know exactly what (and who) supported that submission.
Greg Jewett is the senior director of Strategic Alliances & Partnerships for CRF Health. Their website can be found at: www.crfhealth.com
Alita Hassan: Choosing options for partners to ensure project success has never been more critical for the pharmaceutical industry.
Since the late 90s the pressure to become more efficient and improve profitability has been a key consideration for all outsourcing partners supporting this industry. As we all know, the way our industry has evolved and consolidated has changed the way we conduct clinical trials. Strategic teams managed solely by sponsors have evolved to drive a variety of operational models in the race to efficiency and quality. This trend has given rise to the debate about best practices in outsourcing, from selecting the correct outsourcing partners to managing large global trials with various partners.
The industry is under tremendous pressure based upon international competition, increased regulatory oversight and pricing pressure. Investigational pipelines are decreasing. It is necessary for sponsors to partner with CRO’s to successfully bring a compound to market efficiently. The pressures to make the right decision from a scientific, clinical, regulatory and commercial point of view are increasing. Are you moving in the right direction for successful proof of mechanism? Is there a commercial market for what you are developing? All issues play a part in your decisions. Pressure to execute correctly on those decisions will include selecting the right CRO and then organising people, resources and timelines to complete the project on time and within budget and quality criteria.
Organisational needs to dictate choosing the correct CRO
Do you need global representation around the world, regulatory support, medical support, or just a small niche service? Answering these questions will lead you to evaluate what type of relationship is best; a prospective partner, a full service model, or a functional service provider.
Understanding your needs within your organisation, can help you better identify which CROs are best for you whether it be imaging, full service, IVRS, data management.
Building those relationships allows true synergy with the services provided by the CRO.
Therapeutic strategic alliances can increase trial efficiency
Partnering on a therapeutic basis with the integration of strategic consulting and operations can be a most efficient way to go by providing you with therapeutically focused medical directors providing regulatory consultation as well as regulatory operations support. In addition, consider a full service model to preserve this clear accountability and avoid inefficient hand-off between groups. While small niche CROs can provide strategic alliances, you get the bigger bang for your buck with the full service CRO that meets your needs.
Strategic alliance, the advantages of a most efficient model
The relationship between the sponsor and the CRO is managed by an executive team and not by a study team directly involved with the project.
There are two committees to help support the relationship. One is the operational team, consisting of the director level positions of all the entities to be involved in this relationship and the executive team, consisting of the senior managers. The project is initiated at this point with discussions between the CRO executive team as well as the executive team of the sponsor to make sure that this is a good fit. The sponsor is able to put forward a more long term relationship.
Operational benefits of an alliance
• Ensures proper communication, transparency of operational performance, and timely escalation of essential decision making
• Minimises miscommunication, decision making delays, and frustrations from setting the wrong priorities
• Frees operational staff to focus on primary responsibilities without the day to day oversight of sponsors with limited knowledge of processes and personnel at the CRO level
• Results in cost savings by avoiding cumbersome reporting and management by multiple study teams and redundancy of effort
• Reduces costs in many instances by providing a framework in which the CRO can use appropriate risk management analysis to collab-oratively identify labour (cost) saving processes tailored to the programme
• Reduces costs by minimising sponsor management of multiple vendors.
Best study management practices
Based upon our experience with an alliance model, studies conducted have proven to be well orchestrated during three stages of the project.
Proposal – 1. Protocol review: careful consideration and preparation with the support of medical directors.
2. Strong study feasibilities: key sites consultation about the main inclusion/exclusion criteria potentially affecting the site recruitment.
Study award:
1. Clearly identify the roles and responsibilities.
2. Set defined responsibilities associated with reporting of on target metrics via internet.
Study execution:
1. Use known top performing sites for recruiting highly competitive patient populations.
2. Proactively ask questions that could pose problems.
3. Apply lessons learned from previous studies to study start-ups the next phase of the project.
4. Pre-screen potential patients to expedite patient recruiting at highly desirable sites.
5. Obtain early regulatory approval overseas by working directly with the EMEA.
A carefully well thought-out strategic partnership between a sponsor and a CRO can result in the optimisation of trial quality, time and money.
Alita Hassan, MPH, Medpace Director of Operations/Feasibilities. Visit their website at www.medpace.com
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