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ACROVAN has the most talented and experienced project managers in the industry. We enhance their skills with internal, customer-centric training that ensures clients truly unsurpassed service.

Our project managers act as the liaison with the sponsor to ensure that all deliverables are met. They are committed to maintaining flexibility and cost management. And as leaders of a multidisciplinary operational team, they are empowered to oversee every aspect of clinical trial management and handle changes and new objectives as they arise.

Our project management teams are supported by innovative clinical tools and systems, including our Clinical Trials Management System (Projnet), which provides a variety of reports with up-to-date study information. These customized reports enable project managers to anticipate the next step in the study process and proactively handle potential issues.

Projnet- Clinical Project Management System

     Overall Project Management

     Clinical Site

     Regulatory document (including approval process)

     Patient enrollment and status

     CRF Tracking

     Monitoring

     SAE follow-up

ACROVAN understands that proper planning is key to conducting a successful trial. Through our experienced clinical team, extensive Clinical Research database and customized comprehensive feasibility questionnaires, ACROVAN can provide our customers with the necessary enrollment strategies, timelines and site selections to efficiently initiate a trial.  

At ACROVAN, we understand the right clinical investigators is crucial to the success of your trial. Our Clinical Trial Management System (CTMS) investigator database helps us recruit and select the right investigators for your study, and initiate your trial quickly and efficiently

We ensure efficiency at study start-up by providing a comprehensive binder to the site, detailing the required documentation for your study. We prefer to select clinical investigators we are familiar with to ensure fast turnaround for regulatory document processing and excellence in project execution.

Once a study site is selected and approved, we continue building the site relationship with your project. Experience has shown that constant communication and training increases the sites' willingness to deliver quality data. By establishing and maintaining these site relationships, we can work with these sites on sequential studies, which results in significant time savings and cost advantages.

Everyone of ACROVAN's Clinical Research Associates (CRAs) offers two key attributes: therapeutic expertise and clinical research experience. We seek out monitors with the best credentials in these areas because we know they are critical to the success of your trial.

Our CRAs perform clinical monitoring activities to ensure compliance to the protocol and all regulatory requirements. They also maintain strong relationships with our investigative sites to ensure successful study progress. To maximize our monitors' ability to focus on your study and produce the best results, we strive to assign them no more than two studies at a time.

ACROVAN provides an array of clinical monitoring services to support trials around the world. Our decentralized workforce allows us to maximize flexibility, reduce travel costs, and create an efficient and cost effective monitoring process.

At ACROVAN Biomedical, we know that every clinical study and program requires a thoughtful review

  • CRF Design
  • Database design (SQL Server)
  • Double data entry
  • Data validation and query resolution
  • Medical coding
  • SAS & SQL programming
  • Data Transfer & Integration

ACROVAN offers a number of data operations solutions to meet your needs.

ACROVAN provides:

  • CRF Design, Development & Printing
  • CRF Tracking
  • Database Design
  • Data Entry
  • Data Validation/Cleaning
  • Query Resolution
  • Electronic Data Handling
  • Medical Dictionary Management
  • Medical Coding
  • SAE Reconciliation
  • Quality Control
  • Database Lock

  • Protocol Input
  • Sample Size Calculation
  • Patient Randomizations
  • Analysis Plan Development
  • SAS Programming
  • Data Listings
  • Tables, Figures, Listing
  • Analysis Reports
  • DSMB Support
  • Tailored Tracking Reports
  • Consulting

 

Because our highly qualified global bring profound understanding of the science and technology behind current initiatives, many clients have come to trust in the excellence and timeliness of our work-we're sure you will, as well.

Our global CRAs offer a vast array of experience, expertise, and the enthusiasm it takes to deliver impressive reports that present your material in its strongest, most persuasive case-on time, in compliance, and with the highest quality.

At ACROVAN, we know that regulatory compliance is critical to every study from providing you with country selection/regulatory timeline guidance, preparation and submission management of clinical trial applications to compliance support in auditing and training services that will help ensure regulatory compliance of your clinical program.

Services:

  • Country selection/regulatory timeline guidance
  • Preparation, submission maintenance of clinical trial applications
  • Independent Review Board (IRB/IEC) Audits
  • Trial Master File Audits
  • Final Clinical Study Report (FCSR) Audits
  • Medical/technical writing
  • Database Audits
  • Vendor Audits
  • ICH/GCP training
  • Investigator Meeting ICH/GCP Compliance Training
  • Pre-FDA/Regulatory inspection site preparation
  • Compliance review of Essential Documents for IMP release
  • QA Compliance Consulting

Safety surveillance and Pharmacovigilance are crucial for subject safety and project success. ACROVAN's highly experienced medical and safety team have the expertise, clinical knowledge and proactive approach needed to accurately assess risks and benefits, to help our clients meet and exceed safety objectives and regulatory requirements.

  • Customize safety program
  • Safety expertise into clinical development programs
  • SAE management
  • Maintaining safety database
  • Signal detection and safety trend analysis
  • Medical/technical writing
  • Safety Report Writing

If you would like more information about any of the above services,

please contact us at  shawn@acrovan.com