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Data Management

The Data Management Department

The Data Management Department joins with with the four other service areas to ensure clients receive an integrated service tailored to their needs.

This functional team is experienced in all aspects of Data Management, including design and maintenance of research databases; data staff management; development of standard operating procedures; writing of Data Management Plans; the design and implementation of quality control and quality assurance processes; data validation, SAS programming, and producing descriptive statistical reports.


Services offered by the Department
ACRO provides a range of data management services to help clients produce high quality and timely data.

ACRO data management staff have wide-ranging experience in the multinational environment. Our services are provided in a professional manner and in accordance with international standards.


Clinical Trials
ACRO manages the client's clinical trial data according to internationally accepted standards on a 21CFR Part 11 compliant system. We will optimise resources to ensure that the management of the client's data from case report form development to database lock is carried out efficiently and affordably, either via paper-based CRFs or e-CRF solutions.

During the client's study, ACRO provides customised management reports, data listings and descriptive statistical reports that help the client track the flow of data and understand it fully.


Post Registration Studies
Post-registration studies are used to answer important marketing or medical questions in less time, and at lower cost, than preregistration trials. They are also critical to collect data on real world experience with the product across all countries where the product is used.

AACRO provides a data management strategy which will cut back on time and expense without compromising the quality of the data. ACRO data management staff have extensive experience with post registration studies and have learnt to balance the flexibility and uniqueness of these studies without compromising the quality of the data.


Audits
ACRO carefully designs and plans audits to evaluate whether current data management practices adhere to the client's SOPs, regulatory requirements, and international standards.

Before embarking on the audit ACRO presents the audit plan for client approval, and after completing the audit, presents the findings and recommendations in a comprehensive report.


Data Exploration and Descriptive Statistics
It can be difficult to make sense of large collections of data and to extract meaningful information. ACRO helps the client explore and understand their data by organising and describing it in illuminating ways.


Training
ACRO provides training modules designed to empower data managers. These include:

  • Introduction to Data Management
  • Advanced Data Management
  • Understanding and complying with CFR21 Part 11


ENQUIRIES

For further information, please contact our team using the information provided below:
Tel: +27 (0)11 470 2800
Email: enquiries@acro.co.za