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“As the regulatory environment gets more stringent by the day and pricing pressures increase, drug developers need to do more in terms of compliance and quality and do it more efficiently,” advises Chitra Lele, Chief Scientific Officer, Sciformix Corporation. “Hence many large pharmaceutical companies are using different types of vendors for their specialized expertise areas. Contract research organizations (CROs) are used more for their niche patient recruitment and monitoring skills, and functional service providers (FSPs) are used for other areas such as drug safety, biometrics, clinical writing, regulatory submissions and real world evidence,” she adds.

Sciformix Corporation is a solution provider at the marcus evans Evolution Summit Spring 2017, taking place in Miami, Florida, May 8-10.

How is the clinical trial environment changing?How can pharma companies ensure consistent quality and predictable outcomes in their clinical trials?

The boundaries between safety, efficacy and effectiveness are fading as they are becoming seamlessly integrated throughout the product lifecycle. Companies have to do more to comply with regulations, while the pressure to reduce the mounting costs increases. Hence there is a need to prioritize some activities over others. Those decisions have to be made without compromising the quality of data and the integrity of its analysis must be maintained. Having the right partners is critical, because when it comes to clinical trial conduct some CROs are focused on particular geographies and therapeutic areas, and they have certain strengths and weaknesses. They may have the right key opinion leaders and investigators, and be good at patient recruitment, but may not be able to focus on other aspects of the development programs as much. Use of the right mix of vendors is important, and so is the right amount of oversight.

What are some of the other benefits of working with functional service providers as opposed to full service CROs?

Functional service providers focus on their areas of expertise. For example, we focus on safety and risk management, clinical research, post-approval support, regulatory affairs and regulatory operations. We do not manage clinical trials end-to-end. Clinical study management and patient recruitment skills are very different from those required to carry out the other data, analysis and reporting oriented tasks. It is difficult for organizations, especially the small and mid-sized ones, but sometimes also the large ones, to ensure the required level of expertise and attention across diverse areas. Study management is extremely resource intensive and is the major driver of timelines and cost. Hence areas such as data management, statistics, medical writing and pharmacovigilance often do not get the required focus at the CROs. So many companies prefer to work with FSPs instead of having the CROs provide end-to-end support for clinical trials. FSPs are focused on a few areas and ensure they have the right level of expertise, experience and processes for these. In addition to ensuring high levels of quality, compliance and productivity, choice of the right FSPs can also reduce the burden of oversight for the sponsors.

Can this help accelerate clinical trial timelines? How?

Yes it does, because if pharma companies work with two different providers, one focused on the clinical aspects and one on data management, a lot more can happen in parallel without any compromise on quality and productivity. The major advantage is the quality that the functional service provider can deliver on all aspects of data analysis, safety reporting, etc., which helps avoid any rework. That is where the biggest reduction in the timeline and increase in efficiency can be achieved. Having the right data ensures that what is submitted to regulators is in perfect order. Another specific benefit is that safety data from clinical trials conducted by different CROs can be consolidated into a single database of a safety solutions provider who also has the capability to review accumulating safety data at an aggregate level and help the sponsor be better prepared for regulatory submission and product launch. Functional service providers may also be better at providing post-marketing capabilities for safety surveillance and real world evidence.   

Any final words of advice? 

The location from where services are provided is another consideration while working with FSPs. A global delivery model with off-shore operations can be cost effective. Choice of the right FSP, along with the right skill set available in-house for the right level of oversight can ensure simultaneous realization of quality, compliance and resource optimization.