ACROVAN

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Introduction

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http://www.acrovan.com/home/eindex.php
Acrovan
Type Public / Private
Founded 2001 ( Formerly Biosolution Inc.)
Headquarters Korea

1 ACROVAN is a global, drug development services company, providing a comprehensive range of services to the pharmaceutical, biotechnology, generic drug industries. ACROVAN offers clinical development solutions including (but not limited to) consulting services, Phase I clinical studies, bioequivalency and pharmacodynamic studies, bioanalytical analyses, and Phase II, III, clinical development programs. In addition, ACROVAN has developed technology tools for managing clinical trial data.

ACROVAN provides a positive outsourcing experience through the carefully managed application of industry expertise and effective management of client relationships.

History

2 2001

  • MAY - Biosolution inc. was founded as medical supplies  development vicarious execution agency.
  • SEPTEMBER -  Pharmadex inc. was founded as CRO having clinical speciality.

2002

  • SEPTEMBER - Pharmadex inc. was founded as CRO having clinical speciality.

- Biosolution inc. and Pharmadex inc. entered into companionship.

2003

  • FEBRUARY - The company then concluded contract with MDS pharma and LAB agent (overseas preclinical, clinical, and validation).
  • AUGUST -  The company strategic alliance with Innopath  international (overseas registration and marketing).

2004

  • JANUARY -  The company established Functional foods development team(regulatory affairs) and clinical study team.
  • MARCH - They concluded business agreement with Korea testing and research institute for chemical industry safety evaluation center.

2005

  • FEBRUARY - The company concluded strategic alliance with China CHENGDU WCFP (GLP) institute.
  • JULY -  They concluded strategic alliance with Donga university clinical institute.

2006

  • MARCH - Venture business authentication.

-The company participated in Seoul university veterinary college BK21.

2007

  • JANUARY - The company are partipating organization of Stem Cell Related Regional Innovation System.
  • MAY - They carried out a study assignment of national institute of toxicological research toxicity test.

2008

  • JANUARY - Biosolution inc. combined with Pharmadex inc. to form  ACROVAN inc.

Organization

3
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CLINICAL SERVICES

4 OVERVIEW

ACROVAN offers a comprehensive array of clinical research services to the pharmaceutical, biotech industries. For more detailed information about these services, refer to services page.

  • Project Management
  • Study Planning and Feasibility
  • Site Recruitment and Support
  • Site Monitoring
  • Medical Monitoring
  • Data Capture and Management
  • Data Analysis
  • Clinical Study Reports
  • Regulatory Compliance
  • Safety Surveillance

5 PROJECT MANAGEMENT

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

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.

The 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.

Clinical Project Management System

  • Overall Project Management
  • Clinical Site
  • Regulatory document (including approval process)
  • Patient enrollment and status
  • CRF Tracking
  • Monitoring
  • SAE follow-up

STUDY PLANNING AND FEASIBILITY

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

SITE RECRUITMENT AND SUPPORT

At ACROVAN, understanding the right clinical investigators is crucial to the success of your trial. The Clinical Trial Management System (CTMS) investigator database helps recruit and select the right investigators for providing comprehensive binder to the site, detailing the required documentation for your study. The company prefer to select clinical investigators they are familiar with to ensure fast turnaround for regulatory document processing and excellence in project execution.

Once a study site is selected and approved, they 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.

SITE MONITORING

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.

The 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 the monitors' ability to focus on your study and produce the best results, the company strives 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. The decentralized workforce allows the company to maximize flexibility, reduce travel costs, and create an efficient and cost effective monitoring process.

DATA CAPTURE AND MANAGEMENT

At ACROVAN Biomedical, they 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

DATA ANALYSIS

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

PROGRAMMING/STATISTICS

  • 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

CLINICAL STUDY REPORTS

Because the company's 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 the company's work.

The 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.

REGULATORY COMPLIANCE

At ACROVAN, they 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

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

References

  1. http://www.acrovan.com/home/esub01.php?inc=esub01_02
  2. http://www.acrovan.com/home/esub01.php?inc=esub01_02
  3. http://www.acrovan.com/home/esub01.php?inc=esub01_03
  4. http://www.acrovan.com/home/esub02.php?inc=esub02_01
  5. http://www.acrovan.com/home/esub02.php?inc=esub02_02

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