Uncover forward-thinking solutions with expert consulting

Consulting for Drug Development

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Collaborate with seasoned drug development experts with comprehensive biopharmaceutical and biotechnology experience

Minimize risk, accelerate timelines and avoid pitfalls throughout the drug development continuum

Streamline your outsourcing approach for increased R&D productivity and enhanced performance

Consulting Solutions Designed to Extend Your Resources

As the costs to develop drugs continue to rise, biotechnology and biopharmaceutical companies alike are seeking ways to increase their throughput without increasing fixed costs. Decreasing R&D spend can be achieved through several flexible CRO partnering models, which have evolved to meet the unique demands of today’s drug development landscape. 

An adaptable, fit-for-purpose consulting partnership can deliver results specific to your phase of development and company requirements. Whether you seek regulatory advice or support across the spectrum – from early development to commercialization – you’ll gain a strategic vision and expert execution to advance your program.

Our comprehensive consulting solutions include: 

Nonclinical Development

  • Prospective planning of Lead Optimization, Safety Assessment, Metabolism and Analytical study services
  • Animal model evaluation and selection
  • Full IND/CTA-enabling Program Management
  • Nonclinical Regulatory Strategy
  • Late-stage nonclinical strategies – including DART and CARC timing/planning

Clinical Development

  • Clinical Strategy
  • Regulatory Strategy
  • Target Product Profile
  • Clinical Development Plan
  • Medical Writing & Publishing
  • Chemistry & Manufacturing Controls (CMC)

Market Access

  • Evidence Generation
  • Access & Strategy
  • Value Communication
  • Maximizing Asset Value

Reveal Efficiencies With Relevant Consulting Experience

When seeking support through consulting, you need a team that has a proven track record to overcome challenges, expedite timelines and deliver innovative solutions.

To help position your product for commercial success, leverage our team of industry experienced and specialized advisors for focused guidance. You not only gain access to a wealth of collective knowledge across many functional and therapeutic area backgrounds, but also an evaluation of your options and recommendations for your decision making at each critical development point. With our 250 collective interactions with global health authority agencies and more than 1600 IND/CTA submissions in the last 6 years, you can count on partnering with a consulting team that truly understands the hurdles of drug development. 

Consulting That Creates the Right Results

While scientific and operational expertise is essential to any consulting engagement, the foundation of a consulting relationship is built on a solid communication. We take the time to listen and fully appreciate your unique needs in today’s competitive market.

Let’s form a strategic partnership that enables you to achieve your goals and creates maximum value for your nonclinical, clinical and commercial development programs.

Enable Creative Nonclinical Data Package That Gets You Swiftly to First-in-Human

Now it’s possible to realize up to 30% time savings in your drug development program and maximize the value of your asset. Gain early visibility to the right targets through robust lead optimization efforts. Once a promising candidate is identified, your dedicated early phase development solutions team aligns your nonclinical plan with relevant clinical endpoints and the best regulatory strategy to move your program forward. You’ll expeditiously transition your IND/CTA-enabling program into the clinic for your first in human and proof of concept studies – while maintaining the continuity of a dedicated team, strategy, molecule knowledge and data package.

Increase Your Scientific Continuity With Consulting

Translational science is rapidly advancing to incorporate personalized medicine.  You get comprehensive support for companion diagnostics (CDx) and complementary diagnostics, developed in parallel with your drug. Throughout the journey, you can count on strategic guidance to define your regulatory path, support diverse testing needs and ultimately streamline your operations all the way to commercialization. 

Drive Your Decisions With Real-World Data

High screen failure rates and low enrollment are often the outcome of an overly complex protocol, directly impacting your time to market and patent life. With real-world data from the Xcellerate® Clinical Trial Optimization® Suite and de-identified data from Labcorp patients, you’ll get expert evaluation of specific parameters in your protocol design during planning, development and execution to boost enrollment and reduce the risk of costly amendments. 

Leverage the Power of Expert Consulting

Across the drug development spectrum, you’ll enjoy integrated consulting solutions that efficiently connect the dots between your studies and provide seamless scientific continuity. Get in touch to see how we can work together to power your needs. 

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