Drug Development
A strong development strategy lays the groundwork for every successful therapy.
CMK Select partners with pharmaceutical companies through every stage of drug development—from pre-clinical research to regulatory submission. Our team ensures strategies are actionable, timelines are met, and cross-functional teams remain aligned. With CMK Select as your partner, each milestone is carried out with precision to advance your therapy efficiently and effectively.
Our Role in the Drug Development Continuum
Pre-Clinical Development
We align cross-functional teams to advance early research milestones and candidate selection. Our experts manage Investigational New Drug (IND) studies with a focus on timelines, budgets, and vendor oversight.
Clinical Trials
From planning through delivery, we manage global trials to align clinical teams, CROs, and external partners around shared objectives. With a focus on timelines, milestones, and risk mitigation, we actively monitor progress and maintain documentation throughout the study lifecycle.
Clinical Operations
Strategic oversight and hands-on leadership across studies and programs ensure standardized processes, minimized delays, and operational efficiency.
Biometrics & Data Science
Integrated oversight of biostatistics, programming, and data analysis keeps studies on track and submission-ready. From raw data to final submission, we oversee cross-functional timelines, deliverables, and collaboration across statistical analysis plans, interim outputs, and data-driven decision-making.
Regulatory Affairs
We manage regulatory timelines, dependencies, and gap closure to keep submissions on schedule.
Pharmaceutical Expertise & Resources
Browse curated blogs and case studies that guide your drug development strategy.
Driving Strategic Program Execution for a $14B Global Pharmaceutical Product
CHALLENGE A leading pharmaceutical company’s Development Program Management Team (DPM) was responsible for executing the strategic direction of programs from preclinical through commercialization. This included implementing the Integrated...
Accelerating Oncology Launch: How CMK Select Reduced Delays by 60%
CHALLENGE A leading pharmaceutical company was developing an oncology compound that received FDA Breakthrough Therapy designation, granting expedited approval. With this designation, the company faced a critical challenge:...
The Power of Execution: Building Strong Foundations for Early Drug Development
In early drug development, great science is only the beginning. From preclinical to proof-of-concept, success depends on how effectively organizations translate discovery into disciplined execution. Yet, this stage...
Discover the CMK Way
Built on five core principles: quality, consistency, transparency, accountability, and continuous improvement.
Strategic Kickoff
Every engagement starts with a structured discovery session to ensure alignment and a strong foundation from day one.
Program Leadership
Our project managers embed within your teams to ensure flawless delivery, backed by deep life sciences expertise and a commitment to results.
Progress Reporting
Consistent, transparent reporting that tracks progress, highlights impact, and drives continuous improvement throughout the engagement.
Annual Planning
CMK Select partners with you to review achievements and apply data-driven insights to shape strategic priorities for the year ahead.