Clinical Data Management System Helping to fast-track the drug development process

Clinical Data Management System

In today's research scenario, clinical trials find answer to the research questions by the means of generating data for proving or disproving a hypothesis. This produces large sum of clinical data which has to be organised in most reliable and flexible manner under an efficient management system called as Clinical Data Management (CDM). Clinical Data Management Services has now gradually developed its response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. The main objectives of CDM process is to collect the raw data, ease in monitoring or auditing, and to facilitate processing of the data.

Clinical Data Management System CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards and thus adoption of CDM to drive forward drug research is gaining pace worldwide. It is found that CDM is the key corporate asset in today’s biopharmaceutical industry, and turning data into meaningful information is a critical core function for sponsor firms to make faster and more flexible assessment of the compounds with a specific indication. In forthcoming trials, a CDMS has become necessary to manage the huge amount of data. Many of the CDMS used in pharmaceutical companies are commercial, but there are few open source tool also. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. The open source software can be downloaded from their respective websites.

Electronic Data Capture (EDC) is an alternative which helps to reduce the clinical research cost by 20-28%. The use of EDC technology and eCRF to collect data in clinical trials has grown in recent years and has affected the activities of clinical research operations for industry sponsors, contract research organizations (CROs), and clinical sites. It is found that cost savings alone with EDC vs paper estimated about $60 million per drug. To encounter the particular demand, there is a constant shift from the paper-based to the electronic systems of data management. Developments on the technological front have positively impacted the CDM process and systems, thereby helping encouraging results on speed and quality of data being generated.

While companies are seeking faster access to clinical data, the integrity and quality of data being collected and transferred from study subjects to a clinical data management system (CDMS) must be monitored maintained, and quantified. This ensures a reliable and effective base for not only new drug application (NDA) submission and clinical science reports but also corporate clinical planning, decision-making, process improvement, and operational optimization. FDA has brought forward a critical path initiative in pushing study data tabulation model (SDTM) adoption to enable electronic regulatory submissions for sponsors of human drug clinical trials. SDTM was initiated and developed by CDISC. As a consequence, biopharmaceutical companies have been going major changes in re-evaluating their IVRS, CDMS, clinical trial management system (CTMS), and clinical safety system (CSS) to accommodate the growing needs and demands.

In conclusion, CDMS has now been emerged as an important and reliable tool to materialize the clinical data into useful information which can be further considered to establish as research evidence. Moreover, speed and efficiency of CDMS has also contributed to fast track the drug development process.

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Electronic health records

The Health care industry has undergone dramatic changes over the last few decades. Most of changes revolve around gathering of information and these changes undoubtedly affect both providers and patients. The use of information technology gives access to gather health related information systematically and thereby improves the quality and efficiency of patient healthcare. With the emergence of EHR, the doctors can now instantly access the complete medical information and clinical records of patients on a routine basis.

An Electronic Health Records (EHR) is a digital record of an individual patient collected in computerized format in order to share medical report among multiple healthcare agencies. Digitized health information is a developing concept which can provide very effective and quality solutions for patient care besides helping in reducing costs.


The system is designed to feed all the appropriate conditions of an individual patient or population in a digital format that is theoretically shared across different health care settings. Sharing can also be done by means of network-connected, management information systems and other information networks or exchanges.

In other way, Electronic health record is a source of communication between multiple health care providers to organize, store and manage health data as well as to coordinate a safe, secure and accurate data of an individual patient.




This record constitutes the heart of e-Health that can be implemented for various public health programs for achieving human development in the field of health sector.


Among other types of data, an EHR typically includes:

1. Contact information.
2. 
   
3. Medical history of patient.
4. 
   
5. Medication and allergies.
6. 
   
7. Insurance information.
8. 
   
9. Immunization status.
10. 
    
11. Information about any conditions or diseases.
12. 
    
13. Records of hospitalization.
14. 
    
15. Information about any surgeries or procedures performed.
16. 
    
17. Billing information.
18. 
    
19. Family history.

The governments of many countries are working to ensure that all citizens have standardized electronic health records including the same type of information. However, the major barrier for the adoption of electronic health records is due to high cost involvement.

Functions of Electronic health record systems:

1. Create unique record for each patient including analysis of demographic information of patients
2. Helps in updating patient history
3. Act as source of communication between the professionals and patient records.
4. Lists patient allergic medications and other factors and helps in separating these drugs from a list of common drugs
5. Stores all the data right from the early stage to the final and provides whenever needed
6. Has the ability to register without re-entering medication order by initial data entry from previous data (template for reuse)
7. Allows storing of laboratory results and displays the normal and abnormal results
8. Describes & documents the oral communications and telephone orders for patient

Advantages of Electronic Health Record

1. The entire patient history can be easily viewed without previous medical records and assists in providing accurate, appropriate and legible data.
2. The chance of replication or duplication is reduced as there is only one single file which is constantly updated and it also eliminates the problem of lost forms or paperwork.
3. It is an effective method for extracting medical data for further changes in examination of the patient’s medication profile.
4. Medical records of more than one patient can be easily extracted from EHR database and can be used to gain common characteristics information for other patients, which help in easily and quickly prediction of a disease.
5. Electronic health records are capable of storing, processing or transferring data to the physician far from their patients simultaneously by proper equipment information and communication technology.
6. Electronic health records are very much in demand in healthcare practice and enables professionals to interact with each other effectively. The health data management services mainly use EHR for storing all the information.

Implementing an EMR system

Implementing an EMR system requires careful planning and strong knowledge of trained staff. The following can help make successful implementation of an EMR system at your office.

1. Choose your TPA(third-party application) carefully
2. Ensure connectivity
3. Develop workable templates
4. Training the Staff
5. Establish data security system
6. Prepare EHR details
7. Create harmony between the standard organizations and all interested groups and sub-organizations.

Barriers to implementing an EHR system

1. Incorporation of older paper data into the EHR system
2. Imprecise preservation and long term storage of records
3. Difficulty in Synchrony records
4. Inadequacy of Privacy concern
5. Incompatible with older technology
6. Software maintenance costs
7. Higher costs involved in implementation of a customized system initially.

Due to the challenges and complexities of electronic health records, few people feel uneasy about using electronic medical record software for storing their medical data. On the other hand, there are many people who prefer electronic health records as they feel there is nothing better than digital documentation.

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