Comprehensive Research Solutions
Client-Centric Approach
LyfeSci has a unique client-centric approach to ensure dynamic and personalized service for each project. We envision being your true partner. By maintaining open communication and adapting to evolving requirements, we deliver the best possible support throughout the drug development process.
Tailored IND Solutions
LyfeSci provides tailored IND access solutions through multiple service channels to our clients. Our industry veterans will navigate the complex healthcare and regulatory landscape, ensuring your pharmaceutical and healthcare products receive the dedicated, personalized attention needed to thrive in competitive markets.
Advanced Technology
Our unique, more-than-just-another-CRO structure enables us to deliver customized solutions while leveraging an extensive global network. By harnessing advanced AI technology and innovative operational strategies, we are uniquely equipped to optimize your product's journey from inception to market success.
Our Solutions
Explore our comprehensive range of services designed to accelerate your drug development journey from discovery to market
Pre-clinical Consulting
From concept to IND with expert guidance
Early Clinical Development
First-in-human and Phase I studies
Late-phase Development
Phase II & III clinical trials
Post-marketing & RWE
Real-world evidence and market access
Pre-clinical Consulting
Optimize your pre-clinical development strategy with personalized solutions.
LyfeSci delivers comprehensive pre-clinical consultancy services that seamlessly guide your product from concept to IND—empowering you with the expertise and agility you won't find in a traditional CRO. Our results-driven approach, led by seasoned industry veterans, ensures you receive high-quality data for critical decision-making and robust clinical and pharmacological resources.
By engaging our skilled scientific teams, you'll rapidly advance your lead compounds from pre-IND to IND with confidence. With LyfeSci as your partner, you're assured a clear path to first-in-human trials and poised for success as you accelerate your drug development pipeline.
Early Clinical Development
Design your clinical pharmacology and first-in-human studies to ensure robust results.
In an era where rising costs of drug development compel Pharma and biotech companies to seek efficiencies in research projects, the design of early phase studies and their impact on predicting late-phase outcomes are more critical than ever. As you navigate the intricate landscape of Phase I trials, you deserve a partner that not only appreciates the nuances but also possesses the expertise to propel your projects forward with confidence.
WE WILL DO YOUR PHASE 1 STUDY RIGHT BUT WE ARE HERE FOR YOU BEYOND THAT
Unlike traditional Phase I Units, LyfeSci has also experience in conducting Phase 2-3 trials equips us with a holistic understanding of clinical development. Bridging the gap between early and late phase trials, we underscore the importance of early-phase study design in shaping late-phase outcomes.
Our integrated approach centers on participant safety, data integrity, and operational efficiency, ensuring sponsors move seamlessly from first-in-human investigations to subsequent development phases.
By partnering with LyfeSci, sponsors gain a forward-thinking collaborator devoted to cutting-edge Phase 1 research. From FIMH and SAD/MAD studies to advanced PK/PD analyses, adaptive protocols, and specialized populations, we deliver the crucial early insights needed to propel drug candidates toward successful market entry.
WE WORK WITH MODERN, PARTICIPANT-CENTERED FACILITIES
Spanning over 15,000 square feet in each partner site, our purpose-built clinical units foster a tranquil environment in spacious treatment areas. Whether receiving care in comfortable infusion chairs or fully equipped hospital beds, participants benefit from continuous monitoring of cardiac activity and vital signs, ensuring the highest standard of safety throughout the study lifecycle.
ACCELERATED TIMELINES & QUALITY OUTCOMES
- Real-Time Data Access - Sponsors can securely monitor lab values, ECG data, and vital signs as they become available, enabling swift, evidence-based decisions.
- Rapid Study Closeout - Once the final participant visit is complete, we deliver validated datasets within days—significantly reducing the lag associated with traditional clinical trials.
- Participant-Centric Environments - Our partner sites feature comfortable treatment areas and amenities that boost recruitment, retention, and adherence, ultimately enhancing data quality.
COMPREHENSIVE PHASE 1 CAPABILITIES
- Pharmacokinetics (PK), Pharmacodynamics (PD), and Biodistribution (BD) - Our partner network employs cutting-edge analytical methods to map absorption, distribution, metabolism, excretion, and therapeutic effect—accounting for food effects, drug–drug interactions, and demographic factors such as age and gender.
- First-in-Human (FIH) & Dose Escalation - Our expert teams manage Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) protocols to evaluate safety, tolerance, and early efficacy signals in healthy volunteers or patient populations.
- Bioavailability (BA) & Bioequivalence (BE) - We conduct thorough BA/BE evaluations for biosimilars or generic versions, ensuring robust comparative data on safety and efficacy across different formulations.
- Renal Function & GFR Measurements - Specialized renal studies quantify Glomerular Filtration Rate (GFR) using markers such as Iohexol, Iothalmate, Inulin, or PAH. This capability is crucial for understanding renal handling and risk profiles—particularly in patients with Chronic Renal Failure (CRF).
- Adaptive & Accelerated Protocols - Our flexible trial designs allow real-time modifications based on emerging safety and efficacy data. This approach streamlines decision-making, shortens timelines, and conserves resources for the most promising compounds.
- IV Infusion Studies & Special Populations - Our carefully chosen partners excel in managing complex intravenous infusion protocols, maintaining continuous vital monitoring to ensure participant safety. Our infrastructure readily accommodates trials in populations with Congestive Heart Failure (CHF), malignancies, hepatic impairments, or gastrointestinal disorders—expediting recruitment and delivering highly relevant clinical insights.
Early-Phase Services Include:
Comprehensive Range of Services for Phase I Trials:
- Study design and protocol development
- Regulatory affairs support
- Clinical trial management
- Data management
- Safety monitoring
- Immunogenicity assessment
- Efficacy assessment
Partner with LyfeSci to ensure your early-phase clinical trials are conducted with precision, innovation, and excellence. Together, we can propel your drug candidates toward successful market entry.
Late-phase Development
Transform your late-stage clinical trials with our site-empowerment strategy.
At LyfeSci, we don't just manage Phases II and III clinical trials—we transform them. Our model breaks away from the one-size-fits-all approach by offering unmatched flexibility, site-focused operational excellence, and sponsor-centered precision. We operate as a true extension of your team, delivering customized, high-performance solutions that are agile enough to meet complex study demands—without compromising regulatory integrity.
What sets us apart is our site-empowerment strategy. We embed tailored operational frameworks directly within research sites, enabling smoother execution, faster patient enrollment, and reduced administrative burden. These enhancements come at no additional cost to the site, made possible by our proprietary internal support models that streamline trial operations without disrupting local workflows.
We leverage technology. Our experienced team leverages advanced analytics, AI-driven platforms, and deep therapeutic expertise to accelerate recruitment, optimize protocol delivery, and surface real-time, actionable insights. From feasibility to final data lock, we build strong, transparent partnerships that eliminate bottlenecks and keep studies on track.
With LyfeSci, your trial doesn't just move forward—it advances with clarity, control, and purpose.
We deliver on time, on budget, and with uncompromising quality—empowering your innovation from breakthrough to market with confidence and velocity.
Post-marketing & RWE
Elevate your post-approval strategy with real-world evidence that drives market success.
We elevate Phase 4 and Real-World Evidence (RWE) into a strategic asset. We aim for market access that informs policy decisions and demonstrates the full value of your product beyond the clinical trial environment. In a healthcare landscape defined by value-based care, rising scrutiny from payers, and rapidly evolving patient needs, our RWE and HEOR team delivers added value over traditional CROs: integrated, data-driven insights that speak directly to regulators, payers, providers, and patients.
Our team harnesses high-quality real-world data (RWD) from diverse sources. Our sources through our partner networks include electronic health records, claims databases, disease registries, patient-reported outcomes, and digital health platforms. We combine this with rigorous epidemiologic, economic, and comparative effectiveness methodologies to generate evidence that is both scientifically robust and highly relevant to real-world decision-making.
With every engagement, we provide answers to the questions that matter most such as:
- What are the true unmet needs in the target population?
- How does your product perform compared to current standards of care or key competitors?
- What is the long-term value—clinical, economic, and humanistic—of your product?
- How can this evidence be strategically positioned to support pricing, reimbursement, and formulary inclusion?
We don't stop at analysis. LyfeSci translates this evidence into powerful, stakeholder-ready deliverables—health economic models, value dossiers, payer communication tools, and publications—that support product adoption, health technology assessments (HTA), and sustained market success.
We don't just collect data. What truly sets LyfeSci apart is our collaborative model with sites and sponsors. We embed real-world thinking across the development lifecycle. Our approach bridges the gap between clinical development and commercialization, enabling seamless transitions from regulatory approval to post-market strategy.
With LyfeSci, RWE and HEOR aren't afterthoughts. They're strategic accelerators for your product's real-world success. Whether you are planning Phase 4 observational studies, pragmatic trials, registries, or outcomes research, LyfeSci delivers more than evidence—we deliver impact. Our insights empower you to navigate pricing pressures, demonstrate differentiated value, and secure access in a crowded and cost-conscious market.