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We recognize that to be successful, a study using our technology requires more than just great software. It requires great support and the experience that comes from deploying technology into a variety of countries, settings, and therapeutic specialties.
Our dedication to our customers means that every client receives a premier service and support package. Trial sponsors, investigators, and research staff all receive the same extra-mile support.
Implementing Clinaero Technology
Members of Clinaero's project management team are available to perform remote or on-site assessments of each research site's infrastructure and technical capabilities. Our project manager oversees a team of experts that will configure our technologies according to your study protocol. This includes software set-up, hosting, maintenance, testing, and validation. Our quality management staff ensures that the implementation process is conducted according to Clinaero's Standard Operating Procedures (SOPs) for quality management.
Prior to officially releasing an application, our clients have the several designated opportunities to assess the look, feel, and functionality of their Clinaero technology. This review is compared with the original application requirements. If any additional features or changes are desired, the appropriate documentation is revised and the application re-enters the Software Development Life Cycle. When changes are required and implemented, we perform sufficient regression analysis and testing to demonstrate that the changes did not result in additional errors. Clinaero performs the necessary verification and validation tasks based on the type of change and how the change affects the software's operation.
Project Management
Clinaero's project managers serve as the single point of contact for our clients and assume responsibility for the project's success. The project manager is responsible for the study implementation and utilizes expert clinical and technical resources to ensure successful delivery and execution. Together with the client, our project manager conducts a Clinical Protocol Analysis before the content development and application set-up processes begin. The focus of this review is to determine the best methods for fulfilling the trial's clinical goals and how to meet the requirements necessary to deploy our technology.
Managing Hardware and Telecommunications Infrastructure
Clients can purchase Tablet PCs and other computer equipment on their own or lease them from Clinaero. As a service to our clients, we often manage the device acquisition or leasing process. However, some customers choose to leverage their existing purchasing options instead.
We have validated several wireless and landline operators and carriers that can be used with Clinaero technology in over 30 countries. Additional countries can be validated as needed, based on carrier pre-qualification and local network testing. Clinaero personnel always perform local system testing as part of our overall system validation procedure. When applicable, Clinaero's hosting team administers and supports data transfer from sites to Clinaero's central servers.
Regulatory System Validation
Clinaero products and services exceed the requirements of 21 CFR Part11 for electronic records and electronic signatures. We strive to assist our clients with regulatory compliance. As part of our deliveries, we provide our clients with all the required documentation, including requirements documents, design specifications, and testing procedures and results.
Clinaero's software life cycle follows a strict quality management system. We follow the tenants of ISO9001:2000 for our quality system structure and use ISO12207:1995 as our framework. ISO17799:2000 serves as our guide in managing information security.
Help Desk
Clinaero's project managers respond to calls and e-mails from both site and sponsor personnel. Our content and IT professionals are available 24 hours a day, 7 days a week to help our clients maximize the benefits of their Clinaero technology.
Our centralized help desk is available day or night through one convenient phone number. This saves you the time and frustration of having to call one number for hardware support, another for software issues, and still more numbers for content, consulting, and administrative questions. Through this single point of contact, Clinaero customers find solutions to their every need.
Hosting and Data Archiving
After the User Acceptance Testing (UAT), Clinaero team members install the final system configuration into its hosting environment and validate the installation. In upholding the principles of CDISC, we adhere to ODM standards and export data in XML format. This allows our technology to interface with all the major commercial clinical databases.
We transfer (export) study data to our clients per their unique requirements in a validated manner. Data is stored in our central database servers and our hosting team performs daily backups and periodic offsite storage of data. We maintain the data for a minimum of one year after the end of the study. Longer periods of data maintenance are available as needed.
Clinaero's IT team manages the application and network connections 24/7 for the duration of the trial. The team administers service uptime and changes to the telecommunications infrastructure (e.g. dial-in numbers) as necessary, and our project manager reports performance metrics to the client on a regular basis. Clinaero performs all necessary decommissioning activities at the end of the trial. Upon request, we will provide investigative sites with electronic certified copies of the relevant source data.
Training
Clinaero training modules are designed for three different audiences: the clinical trial team, the site personnel, and the monitoring staff. The goal of the clinical trial team training is to help them understand the implications of utilizing Clinaero technology in their operating procedures. Examples of the issues covered include: best practices in site management, CRA roles and responsibilities, success factors in speeding patient recruitment, and how to leverage real-time recruitment and patient-reported outcomes (PRO) data.
Clinaero conducts a one-day training session at the Investigators' Meeting, consisting of separate training packages to investigators, nurses, study team members, and CRAs. Clinaero provides user manuals for sites and patients in the local language or per the client's request.
Each of the training sessions is documented into training records to comply with Good Clinical Practice (GCP) guidelines and 21 CFR Part 11 requirements. Training consists of an introductory presentation, hands-on training with the application, and role-play scenarios where staff members practice training others on the Clinaero technology. A qualified Clinaero trainer leads each training session.
Device Installations and Logistics
Our device installation process ensures validated software functionality in our technology. Installations include the final version of the Clinaero technology, determined by country and software type. Clinaero software supports all Western languages and Kanji.
The logistical process consists of device shipments directly to the sites and the sponsor's logistics centers, including the appropriate customs declarations documents. Each package consists of the validated device, site instructions, and site manuals. In shipments outside NAFTA and EU areas, Clinaero cooperates closely with the sponsor's drug supply logistics, asset management team, or third-party asset management organizations to manage the customs declarations.
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