First-in-human

We work side by side with Biotech companies to shape study ideas into clear, workable protocols. Our focus is simple: design studies that answer the right scientific questions and can actually be run at the site level. We help define objectives, endpoints, visit schedules and assessments in a way that supports smooth clinical study conduct. The goal is a clear, practical protocol that supports smooth study conduct and meets scientific and regulatory standards.

We support Study Sponsors build study budgets that reflect how the trial will really run, not just how it looks on paper. Our team prepares detailed budgets and supports contract discussions with site and vendors when needed. By addressing costs, timelines, and expectations early, we reduce the risk of later changes. This creates a smoother start-up phase and fewer financial surprises during study execution.

Regulatory work does not have to slow a study down. We take a practical approach to regulatory strategy and submission, focusing on getting things right the first time. Our team prepares clinical trial application or amendment and ongoing correspondence with Regulatory authorities, keeping timelines and local requirements in mind. Clear documentation and early planning help studies move from submission to approval without unnecessary delays.

Our project managers keep studies organized, on track, and moving forward. We coordinate daily activities, timelines, and vendors, making sure everyone knows what is expected and when. Issues are addressed early, before they become problems. With hands-on oversight and clear communication, we help sponsors maintain control of their studies without being pulled into day-to-day operational details.

We conduct clinical studies at the site level with experienced investigators and well-trained study teams. Our focus is on day-to-day study conduct—patient visits, protocol compliance, investigational product handling, and documentation. We follow clear procedures and quality standards while staying flexible when real-life situations arise. This hands-on approach helps ensure patient safety, reliable data, and consistent performance throughout the study.

Finding the right healthy volunteers or patients on time is critical for every study. We support recruitment and enrollment using established database, referral network, and targeted outreach. Our team manages pre-screening, supports informed consent, and works closely with investigators to keep enrollment moving. By staying closely involved throughout the process, we help reduce delays and improve participant retention, even in challenging or competitive studies.

We provide clinical monitoring with a strong focus on patient safety and data quality. Our CRAs work closely with the site to review source data, confirm protocol compliance, and address issues early. Monitoring activities are tailored to the study and may include on-site and remote visits. By keeping communication open and practical, we help Investigational team stay inspection-ready and ensure data can be trusted.

Convex team work closely with investigators and site team from study start to close-out. Our support includes training, regulatory guidance, and day-to-day operational assistance. When questions or issues arise, our team is available to respond quickly and clearly. This close collaboration helps site stay focused, confident, and compliant, while maintaining steady progress throughout the study.

We support clinical studies with coordinated bioanalysis and safety laboratory services. Samples are handled using controlled processes to ensure accuracy, traceability, and timely results. Our teams work closely with clinical operations so that laboratory data supports ongoing safety review and study decisions. This close alignment helps maintain data quality and supports reliable interpretation of study outcomes. For both areas, we rely on long-standing partnerships with specialized providers.

Convex supports these services through collaboration with experienced external provider. We manage clinical data with care from first study participant – first visit to database lock. Our team supports CRF design, data cleaning, query management, and database review. Biostatistical support is closely integrated, allowing for clear analysis plans and reliable results. By keeping data processes simple and well-organized, we help sponsors move from raw data to meaningful insights without unnecessary complexity.

Patient safety is central to everything we do. We manage adverse event reporting, safety review, and regulatory safety submissions throughout the study. Our safety team works closely with clinical and regulatory colleagues to ensure issues are identified, assessed, and reported on time. This integrated approach supports ongoing risk management and helps sponsors maintain confidence in their safety oversight.

Quality is built into our daily work, not added at the end. We maintain clear procedures, regular oversight, and ongoing quality checks across clinical operations. Our QA team supports audits, inspections, and continuous improvement activities. By keeping quality practical and consistent, we help ensure studies are inspection-ready and conducted in line with GCP and regulatory expectations.