Axio fields an accomplished team of specialists in data management and statistical analysis of clinical trial data. From protocol writing and trial design all the way to FDA submissions, we are committed to delivering, on your timelines, high-quality data, thoughtful analysis, and responsive services.
Place your critical biostatistical processes in the hands of experts. Our highly experienced team of PhD and master’s-level biostatisticians will collaborate with your organization in optimally designing, implementing, evaluating, and reporting all phases of clinical trials.
Axio’s biostatistical services include:
- Calculating sample sizes
- Designing randomization plans, including adaptive and seamless approaches
- Developing protocols, sequential monitoring plans, and statistical analysis plans
- Performing statistical analysis and reporting for preclinical through Phase IV trials
Our specialists can also provide statistical guidance and representation at meetings with the FDA and FDA advisory committees.
// Data Monitoring Committees
Axio’s biostatistical group offers deep expertise in supporting data monitoring committees (DMCs). Based on your requirements, Axio can select committee members, prepare your charter, and merge treatment assignments with clinical data. Our comprehensive services for DMCs also include creating and presenting open and closed reports, completing meeting minutes, and providing institutional review board (IRB) notification documents.
We deliver accurate, polished reports within tight timelines and will act as liaison between you and your DMC.
// Clinical Events Committees
You can rely on Axio’s hands-on clinical event committee support services. We will work with you to develop precise definitions accepted by regulatory agencies—and identify reliable and competent committee members from our extensive database. Our services also encompass training clinical sites on providing proper materials, assembling adjudication case packets, and conducting adjudication meetings and teleconferences. Axio’s dedicated team will shepherd each event through the adjudication process with efficiency and attention to detail.
// Medical Writing
Our subject matter experts can provide your organization with the full range of professional medical writing services. These include creating training materials, protocols, investigator brochures, clinical study reports, informed consent forms, integrated summaries of safety and/or efficacy, posters, abstracts, and manuscripts. We deliver your key messages and meet your deadlines.
// Data Management
Rigorous and reliable: Axio’s Internet and paper-based data management services for clinical trials are second to none. Our data management capabilities include database design, case report form (CRF) design, clinical monitoring, data entry, adverse event (AE) and concomitant medication coding, and data cleaning.
// Clinical Trial Networks
Whether you are a commercial or government-sponsored research organization, our team will capably manage your clinical studies network. Axio specialists can provide project management, clinical study management, and site contract initiation and management.
Need to organize and produce meetings of network members? Our team has the capabilities. In addition, in support of your clinical activities, we can develop restricted-access study Web sites as well as public Web sites for patients and families.
Our recent work with the National Institute of Dental and Craniofacial Research’s PRECEDENT network included managing multiple small studies carried out by practitioners inexperienced at clinical trials. We successfully built this network from the ground up, selecting and thoroughly preparing relatively inexperienced sites while managing many simultaneous studies.
// Investigator-Initiated Studies
Streamlined and effective investigator-initiated studies: It’s all about results-oriented design and execution. Axio’s team has significant years of experience in planning studies and developing targeted protocols. We specialize in working with investigators to develop protocols and provide data management, monitoring, and biostatistical support during studies.
We can also assist with publicizing your product capabilities; Axio’s services include preparing manuscripts, abstracts, slides, and poster presentations for journals and meetings.
// Patient-Reported Outcomes
Axio participates in many patient-reported outcomes (PRO) studies and substudies. Our services include developing electronic PRO diaries for computers and smart phones. To develop and test new instruments, we partner with expert epidemiology consultants from the University of Washington.
Axio recently completed a survey study with investigators from Seattle Children’s Hospital using the well-validated Child Behavior Checklist..
// Adverse Event and Medication Coding
We will help you develop coding guidelines and conventions that are tailored to your trial. Our professionals provide quick turnaround times—and stay in communication with your team to make sure these practices perform to your expectations.
Axio outsources concomitant medication coding to our trusted long-term corporate partner ThesIS, Inc.
// Quality Assurance and Control
Axio’s experienced quality assurance team conducts meticulous audits of computer systems, databases, software validation, and test packages. Staff training, standard operating procedures, policies, templates, processes, and study specific procedures are continuously reviewed and updated to incorporate new regulatory guidances and relevant legislation. Our quality management team can also assist in training your staff to prepare for regulatory audits.
// Axio’s Cross-Discipline Expertise—and Cultural Diversity
At Axio, we take great pride in our diverse, open, multicultural talent pool. Axio statisticians and programmers have backgrounds in many industries, including immunology, molecular biology, actuarial science, medicine, public health, health economics, engineering, and supply chain management.
Axio employees hail from every corner of the world. Languages spoken by Axions include Cantonese, Mandarin, Indonesian, Vietnamese, Spanish, Japanese, Macedonian, Bulgarian and American Sign Language.