As result of our experience serving as a Data Coordinating Center for large multicenter trials, Axio has developed an array of additional clinical trial support services that facilitate and expedite the clinical development process.
Clinical Events Committees
Axio staff work with clients to develop precise definitions that will be accepted by regulatory agencies—and to identify reliable and competent Clinical Events Committee members from our extensive database of experts developed during more than 25 years of providing these services. Our CEC services also include training clinical sites on providing proper materials, assembling adjudication case packets, and conducting adjudication meetings and teleconferences. Axio’s dedicated team shepherds each event through the adjudication process with efficiency and attention to detail.
Axio clinical event adjudication services include:
- Selecting and contract with committee members
- Training sites in collection of source documents and completion of CRFs
- Establishing a database to track adjudications
- Training committee members and provide them with a website
- Working with sites to obtain necessary records
- Assembling packets for each case
- Redacting HIPAA-defined data and (if specified in protocol) therapy-specific information that could unblind the reviewer
- Preparing agendas
- Coordinating and attending regular CEC meetings or teleconferences
- Expediting review of discordant events
- Preparing narratives for case presentation
- Preparing periodic reports of adjudication status for sponsors, DMCs, IRBs, etc.
- Serving as liaison between sponsor and CEC
NIH & ACADEMIC RESEARCH
Over the past 25 years, Axio has served as the Statistical and Data Coordinating Center for numerous NIH-sponsored multi-center clinical trials. We have written, submitted, and been awarded a number of proposals to various agencies of the NIH.
Our staff assists trial investigators provide the following types of support:
- Preparation of R01 applications, from initial concept through submission
- Technical support such as sample size calculations and discussion of statistical issues
- Writing assistance—particularly with the statistical and data management sections of proposals
- Administrative support in preparation and shipping of proposals
Once a proposal has been funded, our staff is ready to begin the collaborative process of managing the clinical trial.
We continue to serve as the Coordinating Center for major NIH-sponsored clinical trials in neurology, cardiology, alcohol and drug addiction, and dentistry. A sampling of our NIH experience:
- Stroke Prevention in Atrial Fibrillation (SPAF, NINDS, 2200 patients);
- Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM, NHLBI, 4000 patients);
- Azithromycin in Cardiac Events Study (ACES, NHLBI, 3000 patients);
- Atherothrombosis Intervention in Metabolic Syndrome (AIM-HIGH, NHLBI, 3300 patients).
- In addition, Axio provided data management support for the NW PRECEDENT network, a practiced-based research network in dentistry sponsored by the National Institute of Dental and Craniofacial Research (NIDCR).