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How Our Consultants Work for the Benefit of Clients

Strategic planning, Proactive risk management, Deep knowledge of drug development,  Broad experience and more.

Strategic planning

Clients rely on our consultants to advise them on the correct path for pharmacokinetic and general drug development activities and we work to navigate clients through the inevitable issues on their path.

Proactive risk management

Our consultants are highly experienced and have the foresight to anticipate problems and issues in drug development usually before they become a significant obstacle.

Deep knowledge of drug development by not being “silo’ed”

Our consultants wear multiple hats and work across the board on different aspects of projects from data prep prior to PK analysis to PK/PD analysis, report writing, strategic planning, quality control review, and formatting of documents.  Each week our consultants will typically work on 3 to 5 different projects for different clients.  Since our consultants are not silo’ed they have a wealth of experience and build upon that with each new project/client.

Broad experience

Our consultants are equivalent to senior management at pharmaceutical companies in terms of experience.  We see a large number of diverse projects and complex issues in drug development which means better advice for clients. Our executive staff and Sr. consultants provide hands-on services for clients on a daily basis.

Horizontal vs. Vertical advice

Instead of just advising clients vertically on a single study, our consultants look horizontally across the program and take the time to understand how each study or analysis fits into the big picture and ultimate goals for the program and company.

Knowing the exit strategy

If a company intends to take a compound all the way through NDA then timing and cost implications for clinical pharmacology studies are different then if a company is looking to exit after Phase 2 (i.e., out-license or sell the asset after proof-of-concept data).For example, if a company’s exit strategy is to license or sell a compound by Phase 2 then there are key considerations for when to execute certain clinical pharmacology investigations that might de-risk compounds to make them a more attractive licensing opportunity for partner companies or when not to conduct certain studies due to cost implications that could be better handled by a pharmaceutical company partner with deeper pockets.

Flexibility

We are very flexible and adapt to the changes in clinical pharmacology studies and general drug development programs in order to develop strong relations with the client and provide value-added service.

Integration into R&D teams

Our consultants typically integrate into the client’s R&D team and will often become an extension of client’s internal team.  This sort of interaction builds a team mentality and allows our consultants to have a closer relationship with clients than just a strict client-vendor interaction.  This breeds trust with the client, which translates into successful drug development projects.

Critical Thinking

With a larger knowledgebase of experience and a hands-on approach our consultants provide the day-to-day critical thinking needed for successful PK and PD analyses and overall drug development.

Due Diligence

We provide due diligence services for companies looking to evaluate potential licensing opportunities. Our executive and Sr. level consultants can quickly and efficiently determine the liabilities and positive attributes for small molecule compounds or biologics.

 

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