Phase II to IV
Let’s take your product from concept to approval
AXIS is uniquely positioned to provide cost and time-efficient solutions for
any of your clinical development needs at phases II to IV.
We have established in-depth expertise in Clinical Pharmacology and Early stage development
- We have experience conducting Pharmacology studies for NCE, NBE, Biosimilars, 505(b)(2) and repurposed NCEs
- Our qualified and experienced staff and board-certified dermatologists allow us to execute studies for Topicals and Transdermal products.
- We have proven experience of conducting all type of Clin Pharm studies such as SAD/MAD, DDI, Dose proportionality, FE, hADME, TQT.
- We are the only CRO licensed to perform dOFM studies in the US
We have established in-depth therapeutic area expertise.
Oncology
We have conducted multiple studies across the US in hematological cancers as well as solid tumors.
Dermatology
We combine our highly qualified staff with a proven network of dermatology investigators to give your study the exceptional attention it deserves.
Respiratory
Our team will help in rapid start-up and selection of high-enrollment sites.
Explore our comprehensive CRO services
We handle everything from the big picture to the smallest detail
- Clinical Development and Strategic Consulting
- Clinical Trial Management
- Project Management
- Support Services: Labs, IP Management
- Clinical Monitoring
- Medical Monitoring
- Safety and PV
- Data Management
- Biostats and Medical Writing
- QA & Regulatory Submissions
We offer stand-alone services for your project as well.
Reducing complexity with meticulous planning and real time communication
Our approach
We understand that each project is unique. We start with a structured kickoff meeting to ensure that every project is carefully planned for timely communication and seamless workflow. We strive for quality and precision in study conduct to facilitate regulatory approval.
Our project managers and CRAs maintain real-time communication with the sites to monitor enrollment and study conduct. Our preferred vendor partners help us ensure seamless study execution.
The team’s highest priority is to achieve stakeholder satisfaction
through project engagement to successfully execute the study.
Ensuring quality and consistency in data with robust planning and regular monitoring
Clinical trial success starts early with a robust study design. Our data managers develop effective and comprehensive CRFs to ensure quality and consistent data are collected during the study.
- Appropriate edit checks built to prevent errors
- Extensive training to site staff for data entry and EDC usage
- Real-time remote data validation by raising manual queries
- Robust process for query resolution and data archival
The CRAs perform real-time monitoring to resolve inconsistencies early and perform onsite source document verification to ensure accuracy of the data.
Success Through Transparent and Real-Time Communication
Communication is key
Clear communication at all times is the bedrock of a successful trial. Our project manager and CRAs maintain a close watch on enrollment, study conduct, and vendor supplies. Any potential issues are identified early and brought to the Sponsor’s attention for appropriate resolution.
With our always-on team availability, we have the flexibility needed to respond quickly to any challenge and develop mitigation strategies to reduce risk to project execution.
The team’s highest priority is to achieve stakeholder satisfaction
through project engagement to successfully execute the study.
Comprehensive clinical monitoring by experienced staff
- Our start-up monitoring includes Protocol Training, Therapeutic Training, Pre-study Site Visits, Investigator Meeting/Site Initiation Visit, Staff Training, Site Communication, and Enrollment Strategy
- Our enrollment and maintenance processes involve Site Management Calls, Remote Review, Query Resolution, Protocol Compliance, Training, Enrollment Gaps, Identifying Trends, Issue Escalation, Safety Review, and Essential Document Collection
- Our close-out procedure includes Database Lock Activities, Query Resolution, Closing of Action Items, Close-Out Visit, and Final Essential Document Collection
What the industry is saying about AXIS
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