Clinical data management system Credevo

Clinical data management (CDM) is a critical tool that helps to generate high-quality, reliable, and statistically sound data from clinical trials. Drug companies produce reliable data to win regulatory approval for new medications. Therefore, for a clinical trial to advance the drug development process, an effective CDM is essential.

Clinical data management system Credevo

What is Clinical Data Management (CDM)?

Clinical data management (CDM) is the process of gathering and organizing research data to provide high-quality data that complies with regulatory requirements. Clinical data management (CDM) arose in response to the needs of regulatory agencies and the pharmaceutical industry.

Regulatory authorities now demand the use of quality-assurance standards when gathering the data used in the drug evaluation process in response to the ongoing call to “fast-track” the development of pharmaceutical goods.

Top advantages of an efficient Clinical Data Management (CDM)

  • Provides a global, controlled, standardized data repository
  • Secured data exchange
  • Audit trails & traceability
  • Metadata-driven CRF/eCRF
  • Discrepancy management
  • Transparency
  • Ensures compliance
  • Accelerates clinical trial, and submission

The objective of Clinical Data Management (CDM)

The primary objective of Clinical Data Management is to obtain high-quality data, keep the number of errors and missing data as low as possible and gather maximum data for analysis.

These objectives are achieved by

  1. Data collection Through the paper, electronic, and remote data capture
  2. Data integration – The integration of all data into a single database to ensure consistency and correctness
  3. System/Data validation – Involves User Acceptance Testing (UAT), Quality Control (QC), and programming through edit check programs and manual review

In brief, clinical data management includes the entry, verification, validation, and quality control of data gathered from clinical trials, computer applications, and database systems that support the collection, cleaning, and management of clinical data used in clinical data management.

The goal of a CDM

The goal of any CDM is to ensure that the data drawn from the clinical research supports the conclusions. This helps to protect public health and gain confidence to use therapeutics.

Many organizations outsource the clinical data management process to third-party IT service providers or partners to focus on their core pharmaceutical or clinical research competencies. The process of outsourcing clinical data management helps clinical research companies to reduce their operational expenditure.

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Key steps involved in Clinical Data Management (CDM)

  • Data Collection
    • Generate data from various sources; 
      • Clinical site medical records
      • Laboratory results, and patient diaries
    • In the case of paper Case Report Forms (CRFs), the clinical site records are transcribed onto the CRFs
  • Data Entry
    • Enter data from the CRFs, as well as another source into the clinical trial database
      • Electronic CRFs (eCRFs) allow data to be entered directly into the database from source documents
      • Data from paper CRFs are often entered twice and reconciled to reduce the error rate
  • Data Validation
    • The next step is to check data accuracy, quality, and completeness which is technically called data validation. It often involves queries to the clinical site
    • Once the data is considered final, the database is locked
  • Data Analysis
    • The data is reformatted to report and analyze. Analysts generate tables, listings, and figures
  • Data Presentation
    • After data analysis, the next step is the data integration into high-level documentation such as Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs)
    • The above step is followed by the archival of the database and other study data

How to find the best Clinical Data Management Systems?

The first and foremost thing before you search for a CDM system is identifying your needs. Once you are sure of your needs, then compare the features of various software. You can also compare clinical data management systems by reviewing the installation platforms, pricing, technical support, and the number of allowed users.

The data entry portal should be simple for programs that collect data on paper and send it to data entry staff and allow for double entry and regular oversight.

Top features to look at in a CDM system

To choose a CDM system for your clinical trial, here are some of the features to look for


Clinical Data Interchange Standards Consortium (CDISC) is a multidisciplinary, non-profit organization. It developed standards to support the acquisition, exchange, submission, and archival of clinical research data and metadata.

21 CFR Part 11 
  • 21 is the chapter of US Federal law – Food, Drug & Cosmetics Act 1906
  • CFR is the code of regulation under the US Federal Government law
  • Part 11 is that part which deals with electronic records, electronic signatures, and electronic submissions
  • Part 11 applies to all FDA-regulated industries, which include all drug and medical device manufacturers
  • The U.S. Federal Regulation requires companies to ensure that the electronic records they deal with are trustworthy Click here to know more details about 21 CFR Part 11
HIPAA compliance
  • The Health Insurance Portability and Accountability Act (HIPAA) of the USA sets the standard for sensitive patient data protection. Companies that deal with protected health information (PHI) must have physical, network, and process security measures in place and follow them to ensure HIPAA Compliance.
  • Check more details about HIPAA compliance.

Other compliances as per the local regulatory requirements.

Central storage

All documents should be in a centralized location, accessible, and linked to their respective records. 

Electronic Data Capture (EDC)

  • Direct clinical trial data collection such as Electronic Data Capture (EDC).
  • Research studies can use this data (from interactive web or voice response systems) to enroll, randomize, and manage patients. 

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System installation

Type of system you want a cloud-based or on-premises solution and if you need mobile deployment (iOS or Android).

Investigator and site profile 

This function helps to rapidly conduct feasibility and identify suitable investigators and sites.


The system should offer a calendar, scheduling capabilities, adverse and severe adverse event tracking, trip reporting, site communication, and triggers. 

Number of users 

  • How many users can have access to the software? 
  • Does the software provide levels of accessibility and price based on the number of users?

Patient database 

The patient database is a record of previous contacts that you can potentially draw from for future trials. 

Payment module

Check whether they provide modules to pay stipends, contracts, and other finances related to the research project.

Product costs 

Check whether the software company offers free trials, free or premium options, monthly subscriptions, annual subscriptions, or a one-time license. 

Recruiting management 

This function helps streamline recruitment by targeting potential trial patients with web recruitment and prescreening. 


Use this feature to keep track of visits and events.

Study planning and workflows

This function helps track all the necessary study pieces from the beginning and optimize each piece with workflows. 


Check if the service provider offers 24-hour issue support and training on the software.

Staffing for CDM systems

All staff members, whether a manager, programmer, administrator, medical coder, data coordinator, quality control staff, or data entry person, have differing levels of access to the software system, as delineated in the protocol. The principal investigator can use the CDMS to restrict these access levels.

Clinical data management software assigns database access limitations based on the assigned roles and responsibilities of the users. This coding ensures there is an audit trail, and the users can only access their respective required functionalities, without the ability to make other changes.

Biostatistics in clinical trials

The main goal of any clinical study is to make the best-informed decision based on clinical data gathered and sophisticated biostatistical analyses. Biostatistics is the process of development and application of statistical methods in clinical trials. It encompasses the design of clinical trial experiments, the collection, and analysis of data from those trials, and the interpretation of the results.

  • Biostatistical methods will contribute at every stage of clinical trials right from study design to interpretation of results.
  • For example biostatistics help in identifying the optimal dose by using advanced, well-established, and regulatory-acceptable statistical methods for dose-finding.

Learn more about biostatistics and it’s importance in clinical trials

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