Skip to main content
search

Early Clinical Development Solutions

Expert Support at Every Stage from Candidate Selection through Phase 1

Contact us

Your partner in Early Development success

Successfully navigating the complexities of early clinical development requires deep expertise and a strategic approach. Certara provides tailored solutions to overcome the high costs, long timelines, and attrition challenges of drug development. Our flexible, scalable frameworks ensure your candidate progresses efficiently, paving the way for funding, partnerships, and long-term success.

Streamlined development framework

We offer a flexible, scalable model based on decades of experience, ensuring efficient execution across early development stages.

Expert resources

Access a team of 700+ scientists with expertise in end-to-end drug development to guide your program strategically.

Integrated insights

Our cross-functional approach integrates innovative technology for data-driven decision-making.

Proven results

Certara has supported 90% of FDA-approved novel drugs since 2018

Early Development solutions designed with you in mind

Certara’s cross-functional team members flex in and out based on your needs, with a dedicated program lead – ensuring continuous, scalable coverage.

TPP & development strategy

Develop a product strategy by assessing competition, viability, pricing, market access, and regulations.

IND-enabling/FIH planning, design and regulatory strategy

Develop functional plans, drug development strategies, and study designs to ensure TPP alignment.

IND/FIH-enabling execution and reporting

Oversee drug development, non-clinical studies, vendor management, DMPK analyses, and translational modeling.

IND authoring & submission

Prepare and submit regulatory documents, including FIH protocol, Investigator Brochure, and IND/CTA filings.

FIH execution / reporting

Guide CRO selection, manage study execution, analyze data, and prepare for the next development phase.

Explore our Early Clinical Development solutions

Chemistry, Manufacturing, & Controls

Optimize CMC strategies for early development success.

Learn more

Toxicology services

Ensure safety and compliance with expert toxicology support.

Learn more

DMPK Consulting

Accelerate early development with advanced DMPK insights.

Learn more

Regulatory affairs consulting

Navigate regulatory landscapes with Certara’s expertise.

Learn more

Meet our experts in Early Development

Fran Brown, PhD
1 / 3
Experts

Fran Brown, PhD

Senior Vice President, Certara Drug Development Solutions

Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing.  She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).

Kevin Hershberger, BPharm, MBA
2 / 3
Experts

Kevin Hershberger, BPharm, MBA

Vice President Certara Drug Development Solutions

Kevin brings 25 years of experience in the pharmaceutical industry primarily in project leadership roles and provides integrated program management (integrated plans, Target Product Profiles, and financial planning clients, including fund raising, business development, client presentations, and vendor selection.  He has held leadership and ma...

David Mitchell, PhD
3 / 3
Experts

David Mitchell, PhD

SVP Clinical Pharmacology Certara Drug Development Solutions

David Y. Mitchell, PhD, has over 30 year’s experience in clinical development, strategic drug development, and project leadership. Dr. Mitchell earned his PhD in pharmaceutical sciences from the University of Colorado and completed a postdoctoral fellowship in the Department of Pharmacology, Toxicology, and Therapeutics at the University of K...

Why choose Certara for Early Development?

Certara’s proven track record in early clinical development ensures your program is guided by unparalleled expertise, scalable solutions, and innovative frameworks. Our team combines scientific depth with a forward-thinking approach to help you achieve success.

Contact us
700
drug development scientists and experts to advance your program leveraging tech-enabled decision-making
>90
of all novel drugs approved by the US FDA since 2014 were supported by Certara tech-enabled solutions
400
MD, PharmD, and PhD drug development scientists
7
of Certara's scientists are recognized as top 2% most cited

Related resources

View all
1 / 4
Fact Sheet

Certara Strategic Early Development Solutions

A comprehensive guide to optimizing early development strategies.
Read more
2 / 4
Blog

Why You Need an Integrated Development Plan

For a small biotech company developing its first drug asset, the path is fraught with challenges. The complexity of drug development requires balancing strategic planning, thorough expertise, and substantial financial...
Read more
3 / 4
White Paper

Why Performing Key CMC Activities Early Can Aid De-risking Your Drug Development Program

This white paper focuses on best practices for developing a CMC strategy for orally administered small molecule drugs
Read more
4 / 4
Blog

Why you should select your drug formulation before starting clinical studies

Drug developers often rush through the discovery process to get into human testing. Most are so curious about their new target or molecule that they may forget that the pharmaceutical...
Read more

Contact Certara for Early Development expertise

Partner with Certara to ensure a strategic and successful approach to your early clinical development needs. Our team of experts is ready to assist with tailored solutions designed to optimize each stage of your program.

Over 90% of FDA-approved drugs since 2014 used Certara’s services or technologies.
700+ world-class scientists and experts driving drug development success.


Discover more Certara services

Our experienced pharmacometrics services team helps quantify drug-patient interactions, optimize development & regulatory choices.

Read more

Certara’s Market Access & Commercial solutions provide strategic insights and tools to optimize pricing, reimbursement, and market entry strategies.

Read more

Advanced biostatistics consulting and CDISC-compliant SDTM & ADaM datasets

Read more

FAQs

What is included in Certara's early clinical development solutions?

Our solutions span Candidate Selection to Phase 1, providing expertise in CMC, toxicology, DMPK, regulatory affairs, and more.

How does Certara's framework benefit early development?

Our flexible, scalable model reduces complexity, improves timelines, and integrates cross-functional expertise for optimal outcomes.

Why should I choose Certara for my drug development program?

With decades of experience, 700+ experts, and a proven track record, Certara ensures your early development program is positioned for success.