Our Services
Breakthrough Research Projects Shaping Future Innovations
Real-World Case Studies Driving Scientific Advancement
Early Phase Development
Clinical Trial Design & Protocol Development
Our team of experienced scientists and clinicians collaborates with sponsors to develop scientifically sound and operationally efficient clinical trial protocols. We focus on optimizing study endpoints, patient populations, and statistical methodologies to ensure high-quality data and successful outcomes. From Phase I to Phase IV, we cover all therapeutic areas.
Regulatory Compliance
Regulatory Affairs & Submissions
TialPath Research Solutions provides comprehensive regulatory strategy and submission services. We assist with IND/CTA applications, NDA/BLA/MAA submissions, and post-marketing commitments across major health authorities (FDA, EMA, PMDA, etc.). Our experts ensure all documentation meets stringent requirements, minimizing delays and maximizing approval potential.
Clinical Operations
Patient Recruitment & Retention
Successful clinical trials depend on effective patient enrollment. We employ data-driven approaches, digital outreach, community engagement, and site-specific strategies to identify and recruit diverse patient populations. Our retention programs focus on patient support and communication to minimize dropout rates and ensure study completion.
Data & Analytics
Data Management & Biostatistics
Our data management services ensure the collection, cleaning, and validation of high-quality clinical data using industry-leading EDC systems. Coupled with our biostatistics expertise, we provide comprehensive statistical programming, analysis, and reporting, transforming raw data into actionable insights that support critical decision-making.
Post-Market Surveillance
Pharmacovigilance & Drug Safety
TialPath Research Solutions offers robust pharmacovigilance services, including adverse event collection, causality assessment, expedited reporting, and aggregate report generation (PSURs, DSURs). We establish and maintain global safety databases, ensuring compliance with international regulations and safeguarding patient well-being.
Clinical Operations
Clinical Site Management & Monitoring
Our Clinical Research Associates (CRAs) provide meticulous site selection, initiation, routine monitoring, and close-out activities. We ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements, fostering strong relationships with investigators and site staff to drive efficient trial execution and high-quality data collection.
Early Phase Development
Phase I Clinical Trials
Our Phase I clinical trial services focus on meticulously evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of novel compounds in healthy volunteers or specific patient populations. We leverage state-of-the-art facilities and experienced medical staff to ensure precise data collection and patient well-being, adhering to the highest ethical standards and regulatory guidelines.
Late Phase Development
Phase II/III Clinical Trials
TialPath Research Solutions excels in managing complex Phase II and III clinical trials, designed to demonstrate the efficacy and further assess the safety of investigational drugs. Our global network of trial centers, advanced patient recruitment strategies, and rigorous data management ensure high-quality results that support regulatory submissions and market access. We focus on therapeutic areas including oncology, neurology, and rare diseases.