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 ensure to generate trustworthy and quality data to gain approval from the regulators for new drugs. Thus, an efficient CDM in a clinical trial is important to advance the drug development process.

Clinical data management system Credevo

What is Clinical Data Management (CDM)?

Clinical data management (CDM) is a process of collection and management of research data to obtain quality information as per the regulatory standards.

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, database systems that support the collection, cleaning, and management of clinical data used in clinical data management.

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.

Key steps involved in the Clinical Data Management (CDM)

  • Data Collection
    • Generate data from various sources. Common examples of source data are 
      • 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 and 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 archival of database and other study data.

Tools for Clinical Data Management

There are many software tools available for data management, and these are called Clinical Data Management Systems (CDMS). The use of these tools in multi-center trials has become obvious as they help to manage a huge amount of data.

The commonly used tools in CDM

  • Oracle Clinical,
  • Clintrial,
  • Macro,
  • Rave, and
  • eClinical Suite.

The functionality of all these software is more or less the same. These software tools are expensive and need sophisticated (IT) Information Technology infrastructure to function.

Some giant pharma companies use custom-made software for data management while small range companies use open-source software.

Few of them include

How to find the best Clinical Data Management Systems?

The first and foremost thing before you search for a CDM system is to identify your needs. Once you are sure of your needs, then compare the features of various software. Along with this, 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.


Need support for your clinical trials?

Do you have any queries or requirements related to Clinical Data Management? We have the expertise to help guide you in every stage of drug development. Complete the form below to connect with us.


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

Compliance 

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 a 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 link 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. 

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.

Monitoring 

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. 

Scheduling

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. 

Support

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.


Do you have any queries or requirements related to Clinical Data Management?

Talk to us today. Provide preliminary details below, and we will help you achieve your clinical data management objectives for clinical trials.

Provide brief info about what kind of support you are looking for
Provide your work email, where we can contact you