Full-service versus Functional

For small-mid-sized biotechs, choosing a partner who is a full-service provider versus a functional provider can increase the probability of success. The more partners involved, the higher the chance for conflicts in the drug development process. This can impact costs and milestone success.

“When we can fully engage with our medical, regulatory and operational teams and work under our SOPs, we can perform at the highest levels to deliver quality results in the most timely and efficient manner. Competence and empowerment to coordinate all services under one roof provides an accountable, seamless, integrated and efficient platform – increasing quality and speed while significantly reducing a Sponsor’s need for duplicate management oversight.”
August Troendle, MD, Medpace Founder and CEO since 1992

Over our 25-plus year history, Medpace has steadfastly held to a model of providing full-service clinical development services. This model is best suited for biotechs looking for a true partner and we know from our long-standing relationships that the full-service outsourcing model ultimately delivers higher quality results.

Solution-oriented Project Teams

In a continuously changing and challenging industry, flexibility and problem solving are critical. Medpace’s ability to adapt to unexpected problems and a streamlined decision-making structure helps keep clinical development on track.

“We have the culture and the organizational structure to quickly address unexpected issues. It is very important not to desperately stick to the path you’re on, but to think of alternative scenarios in case things don’t work out the way they were planned. Our teams are constantly working through proactive contingency plans and even backup plans for the backup plan. Medpace’s foundation in the medical sciences, our sense of responsibility and ownership, and our spirit of partnership keep us moving forward to reach milestones.”
Reinilde Heyrman, MD, Vice President of the Medical Department at Medpace

Medpace projects teams are structured to balance disciplined execution with empowered action. For example, the project management team is structured to focus on study milestones rather than revenue generation, ensuring they are fully engaged with your study. Importantly, therapeutic and regulatory experts are embedded in the teams to provide guidance along the way and to ensure the study does not go off track.

An Extension of Your Team

Emerging biotechs often lack the full-scope of resources necessary to take compounds through all stages of drug development and on to approval. Medpace’s depth of medical, regulatory, and operational expertise—as well as wholly-owned integrated labs and imaging—provides the resources and services that enrich and strengthen your team.

“Drug development is multifactorial; it requires expertise in a number of focus areas, including chemistry, nonclinical, clinical, and regulatory. As such, smaller companies without these resources are challenged to develop and adhere to a strategy that is developed with an end goal in mind—one that will allow for marketing in the desired patient population, for the desired indication, at the desired dosing regimen. Medpace can truly streamline development because of our full breadth of services and collaborative model; we offer a full partnership rather than an ‘extra set of hands.”
David Horton, Director of Regulatory Affairs at Medpace

Medpace works collaboratively and seamlessly with your team to execute clinical studies at the highest level of quality. Our comprehensive services and industry relationships help to ensure we can provide the best resources and guidance to efficiently execute your studies.

Right-sized for Responsiveness

Selecting the right CRO partner is one of the most critical decisions a biotech makes. As a mid-sized CRO with global capabilities, Medpace is big enough to manage challenging trials of all sizes, yet small enough to give you the attention and focus demanded by your stakeholders.

“Find a partner who will not deprioritize you because of your small size or limited immediate pipeline. At Medpace, we form collaborative relationships and our teams are invested in the science of your products as much as you are. At the same time, we are large enough to conduct complex trials globally, yet small enough to maintain a higher level of commitment.”
Andrew Masih, Executive Director of Clinical Trial Management at Medpace

Biotechs are confronted with an ever-changing slate of top priorities. The ability to fully rely on your CRO to execute studies almost independently allows you to focus on other issues. At Medpace we build our relationships on a foundation of trust and we share the same commitment to your compound that you do.

Experienced Execution

Challenging science coupled with complex regulatory frameworks require an experienced CRO. Selecting the appropriate partner with drug development expertise and regulatory experience is crucial to ensure robust study designs and to facilitate efficient clinical trial execution, as well as impactful agency and site interactions, and regulatory submissions. It is critical to have advanced knowledge of the disease, endpoints, sites, patient access and so on.

“We only work where we are confident that we can truly add value. All of our executions start in the medical science. We bring with us a sense of responsibility and ownership, and we really want to be the right partner, the seamless extension of the sponsor team, to help them get this new therapeutic modality to market.”
Reinilde Heyrman, MD, Vice President of the Medical Department at Medpace

As drug development continues to become more complex with advances in immuno-therapies, gene and cell therapies, and microbiome therapeutics as examples, experience in a specific indication is no longer as critical for running clinical trials. Medpace can apply its medical and regulatory foundation across therapeutic areas and diseases, rare diseases and orphan indications, as well as leading technologies and platforms to optimize your study. This “cross-pollination” of expertise allows us to apply our experience and relationships to an extensive range of diseases.

We can’t simplify clinical development, but we can execute it seamlessly.

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