Our Research Capabilities
Discover our comprehensive suite of scientific capabilities that drive innovation and excellence
Early Discovery
Strategic Guidance from Idea to Preclinical Candidate
At LyfeSci, our Early Discovery services are delivered through a consulting model designed to guide biotech and pharmaceutical innovators through the critical early stages of drug discovery—transforming promising biological hypotheses into validated preclinical candidates ready for IND-enabling studies.
We offer expert strategic, scientific, and operational consulting across the entire Early Discovery continuum. Our clients benefit from access to seasoned drug hunters, translational scientists, discovery program managers, and physician investigators who provide ground-level insight to embed directly into strategy.
Key stages we support include:
- Target Identification & Validation – assessing novel biological targets using literature, omics datasets, and disease biology insights, and designing validation strategies via external vendors or academic labs
- Hit Discovery Strategy – advising on platform selection such as high-throughput screening, fragment-based discovery, DNA-Encoded Libraries (DEL), or in silico methods, and connecting clients with trusted assay partners
- Hit-to-Lead Optimization – triaging hits based on potency, selectivity, novelty, and developability, and guiding early Structure–Activity Relationship (SAR) efforts with external chemists
- Lead Optimization & Candidate Selection – managing lead refinement through medicinal chemistry, in vitro pharmacology, and Absorption, Distribution, Metabolism, and Excretion (ADME) profiling, while aligning with Target Product Profiles (TPPs)
- Translational Planning & IND Pathway Preparation – defining biomarker strategies, disease models, and clinical differentiation plans to ensure a seamless transition into IND-enabling development
Clinical Development
Our Clinical Development team designs and executes innovative clinical trials across all phases of development. We combine scientific expertise with operational excellence to deliver high-quality data that advances therapeutic candidates efficiently through the development pipeline.
From first-in-human studies to pivotal trials, we implement patient-centric approaches that optimize recruitment, retention, and data quality. Our adaptive trial designs allow for flexibility while maintaining scientific integrity and regulatory compliance.
Our Expertise:
- Protocol development and optimization
- Site selection and management
- Patient recruitment strategies
- Adaptive trial designs
- Risk-based monitoring
- Clinical trial management systems
- Global regulatory compliance
We leverage digital technologies and innovative approaches to streamline processes, enhance patient engagement, and generate robust evidence that supports regulatory submissions and clinical decision-making.
Pharmacovigilance
At LyfeSci, our pharmacovigilance services are built on a foundation of clinical rigor, regulatory compliance, and global responsiveness. Whether through risk-based monitoring or a traditional approach tailored to your study, our in-house team of U.S.-based, board-certified physicians brings firsthand therapeutic expertise and real-time medical oversight to every safety evaluation—ensuring your data is interpreted by those who understand both the science and the regulatory stakes.
From IND through post-marketing surveillance, we support the full spectrum of drug safety monitoring. Our capabilities include:
- Full-service Medical Monitoring
- Case processing (Serious and Non-Serious AEs)
- Aggregate reporting of all kinds
- Safety narratives and regulatory response preparation
- Periodic Adverse Drug Experience Report (PADER) and signal detection
We partner globally—leveraging established collaborations across the globe—to provide continuous coverage, multilingual reporting, and local regulatory insight. Whether you are navigating FDA, EMA, or PMDA requirements, we ensure your pharmacovigilance strategy remains globally compliant and inspection-ready.
At LyfeSci, pharmacovigilance is not outsourced to call centers—it's led by a U.S.-based team, including licensed physicians and drug safety professionals who are embedded in your clinical journey.
Clinical Pharmacology
Whether you want to utilize our network of clinical pharmacology and Phase 1 units or are seeking expert consulting in clinical pharmacology, we are ready to deliver.
We engage a curated network of experienced clinical pharmacologists, modeling experts, and regulatory consultants to meet the precise needs of your compound and development strategy. Our experts advise on the design, analysis, and interpretation of pharmacokinetic (PK), pharmacodynamic (PD), and drug–drug interaction (DDI) studies—ensuring you generate the right data to support regulatory filings and decision-making.
Key services include:
- First-in-Human and Dose-Escalation Strategy
- PK/PD Study Design and Protocol Development
- Population PK and Exposure–Response Modeling
- DDI and Food Effect Assessment
- Clinical Pharmacology Sections for INDs, NDAs, and CTDs
- Regulatory Interactions (e.g., FDA Clinical Pharmacology Reviews, Q&A Preparation)
With our flexible approach, sponsors benefit from deep expertise without overhead, rapid team assembly, and the ability to scale support as programs evolve. We act as your strategic pharmacology partner—ensuring clinical-phase decisions are informed by rigorous, translational science.
Biostatistics
Our Biostatistics team provides expert statistical design and analysis for clinical trials and observational studies. We develop robust statistical methodologies that maximize the information gained from research while maintaining scientific integrity.
From early phase dose-finding studies to complex adaptive designs and Bayesian approaches, we implement innovative statistical methods that optimize trial efficiency and increase the probability of success. Our statisticians collaborate closely with clinical teams to ensure alignment between study objectives and analytical approaches.
Statistical Expertise:
- Sample size and power calculations
- Randomization scheme development
- Adaptive trial design
- Interim analyses and data monitoring
- Bayesian statistical methods
- Complex endpoint analysis
- Real-world evidence analytics
We leverage advanced statistical software and programming expertise to deliver high-quality analyses that support regulatory submissions, publications, and strategic decision-making throughout the product lifecycle.
Clinical Data Management
Our Clinical Data Management team ensures the collection, validation, and management of high-quality clinical trial data. We implement robust processes and systems to maintain data integrity throughout the research lifecycle.
Using state-of-the-art electronic data capture systems and standardized processes, we streamline data collection while maintaining compliance with regulatory requirements. Our approach emphasizes data quality, traceability, and accessibility to support efficient analysis and reporting.
Key Services:
- Database design and validation
- CRF/eCRF development
- Data validation and cleaning
- Query management
- Medical coding (MedDRA, WHO Drug)
- SDTM and ADaM dataset creation
- Data standardization and CDISC compliance
Our integrated data management solutions combine technological expertise with clinical knowledge to deliver high-quality, analysis-ready data that supports regulatory submissions and scientific publications.
Regulatory
Our Regulatory Affairs team navigates complex global regulatory landscapes to optimize development strategies and submission pathways. We provide strategic guidance and operational support throughout the product lifecycle.
With expertise across major regulatory jurisdictions, we develop tailored strategies that align scientific objectives with regulatory requirements. Our team maintains current knowledge of evolving regulations and guidance to ensure compliance while optimizing development timelines.
Regulatory Services:
- Regulatory strategy development
- Agency meeting preparation and representation
- IND/CTA preparation and maintenance
- NDA/MAA preparation and submission
- Regulatory intelligence and gap analysis
- Labeling development and negotiation
- Post-approval regulatory maintenance
Our integrated approach combines scientific expertise with regulatory knowledge to develop strategies that maximize the probability of regulatory success while optimizing development timelines and resources.
Decentralized Trials
Our Decentralized Trials capability leverages digital technologies to reimagine clinical research, bringing studies directly to patients. We design and implement innovative approaches that enhance recruitment, improve retention, and generate high-quality data.
By combining remote monitoring technologies, telemedicine, and direct-to-patient services, we create patient-centric trial experiences that reduce burden while maintaining scientific rigor. Our approach integrates traditional clinical research methods with innovative digital solutions.
Innovative Solutions:
- Remote patient monitoring
- eConsent implementation
- Telemedicine visits
- Home healthcare services
- Direct-to-patient drug supply
- Digital outcome assessments (eCOA/ePRO)
- Wearable and sensor integration
Our decentralized trial solutions expand access to clinical research, enhance the diversity of study populations, and generate real-world insights while maintaining compliance with regulatory requirements and data quality standards.
Medical Writing
At LyfeSci, our medical writing services are designed to bring scientific clarity and regulatory precision to every stage of your clinical development journey.
We specialize in crafting clear, accurate, and fully compliant documents that meet the highest standards of global health authorities. With deep expertise across therapeutic areas, regulatory frameworks, and publication standards, our writers translate complex data into compelling, submission-ready content.
From clinical trial protocols and investigator brochures to manuscripts and regulatory modules, we ensure your message is both scientifically rigorous and strategically aligned.
We focus on efficiency and consistency, while maintaining full medical and regulatory oversight. Whether you need rapid turnaround or highly specialized support, LyfeSci delivers documentation that reflects the strength of your science.
Key Medical Writing Services Include:
- Protocols, Amendments, and Investigator Brochures (IBs)
- Clinical Study Reports (CSRs) and Safety Narratives
- Chemistry Manufacturing and Control (CMC) manuals
- IND, NDA, BLA, and CTD Module Content
- Manuscript Development and Journal Submission Support
- Literature Reviews and Gap Analyses
- Patient-Facing Materials and Lay Summaries
- AI-Assisted Drafting with Expert Oversight
- QC Review and Document Formatting for Compliance
