AXIS Clinicals USA offers the gold standard in expertise and timeliness when it comes to Healthy Volunteer studies.
With over 150 years of collective upper management experience plus over 75 years of middle lab management expertise, we offer quick turn-around, flexible scheduling and on-site bioanalysis which allows immediate sample analysis when required. Whether you need First-in-Man, PK/PD, SAD, MAD, DDI, Food Effect, Cognitive Testing, Bioequivalence (cross-over, parallel, or replicate or Fast-toFile), our team of experienced staff can seamlessly support you from protocol development all the way through to final eCTD report.
To date, AXIS Clinicals USA has dosed capsules, tablets, patches, sublingual films, injectables, IV infusions, immediate and extended release tablets/capsules, eye drops, inhalers, nose drops, topical products including shampoos and lotions, as well as suspensions, sublingual tablets and gummy products. This knowledge and experience has prepared the team to dose unique new drug delivery systems across many therapeutic areas with unique delivery forms and routes of administration.
Our recruiting team has a history of efficient enrollment in multiple subject populations, including healthy males and females, older adults, smokers, menopausal women and renal or hepatic impaired.
Our clinical staff has experience in running clinical trials for innovator as well as generic pharmaceutical clients, including multiple study designs, dosage forms, and a wide variety of sponsor requirements. The clinical units are in close proximity with our licensed, pharmacist managed pharmacy capable of handling all Schedule II-IV controlled substances. Schedule I licensing should be available with ample lead time. The pharmacy also has experience with limited non-GLP compounding and/or dosing preparation. All investigational products have a check, double-check pharmacist controlled process for receiving and dispensing. Our pharmacists also have an active role in dose administration.
The in-house bioanalytical laboratory offers method development, assay validation, and sample analysis in compliance with FDA and international regulatory requirements as put forth by ICH. Self-monitoring is conducted with a constant in-process check by quality control staff reporting to laboratory management. Upon completion of sample analysis, Incurred Sample Re-analysis (IRS) is completed as per protocol and regulatory requirements. Axis QA completes an overall review of the data and processes to assure the protocol, SOP’s and regulatory requirements are/were followed and reported as required.
Our statistics, pharmacokinetic analysis, report writing, and data management is located in our Hyderbad, India office but is closely connected to our US site by phone and hourly texts. All related efforts are team oriented from project abstract to final report.
Axis Clinicals’ appeal to the general study volunteer is secondary to a very friendly staff, great food, spacious study units, and reclining phlebotomy chairs for both comfort and safety. The volunteer’s voice is heard and understood by management, as well as clinical staff.