Showing posts with label clinical data management. Show all posts
Showing posts with label clinical data management. Show all posts

Tuesday, 4 March 2014

How SPLIFE’s Data Management Services Work ?

Data Management Service
Data Management is done to provide high quality valuable data and it is a important stage in the clinical data management .  It is done to avoid the data management process easy and more efficient. The best possible results, more accuracy and a clean and continuous access to the solutions are provided. The data management services are provided on paper, hybrid study and on EDC.

SPLIFE makes sure that the creation of the results is done as per the standard procedures and also tried to maintain the level as per them. The protocols are then analyzed by the team and their inputs are taken into consideration. The results of the data management are reviewed and go through some of the stringent procedures like Medical coding, Data entry, Discrepancy management, edit check programming and also provides support to the serious adverse effects. SPLIFE is the pioneer in providing the data management services in the country and have various services to meet the client expectations. These services are reliable and genuine and one can expect accurate and best results. SPLIFE is committed to customize data management solutions with complete transparency, accountability and integrity. Some of the measures that SPLIFE uses to deliver the best data management solutions are Precision which helps the clean and reliable solutions and promote accurate data collection. Speed plays a major role in the data management service. High speed means the faster results and the production, time will be less. Proactive services help efficient services, early problem solving and reduce the overall production time.  The comprehensive services that are done with other activities are CRF designing, Data entry and verification and edit check specifications. The clients vision is turned into reality with accurate and realistic solutions which helps with the cost savings and the reduce time consumption of the client. 

Wednesday, 22 January 2014

Why Clinical Data Management is Required ?


Clinical Data Management is the process of handling a data that is acquired from the clinical trial.  Clinical Data management has the aim to protect the data and maintain quality data. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.

There is a data flow, which has to be followed during the process. Once subject enrolment begins, the clinical data manager ensures that data is collected, validated, complete and consistent. 
Standard Operating Procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities. 

At the completion of the clinical trial, the clinical data management ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data management transfers data for statistical analysis.

Clinical Data Management is a very important tool for managing the medical data. This process is important because imaging a hospital with a lot of patients and medical records, but unable to manage them properly. These were the traditional way to have records on paper. But with the clinical data management methods, clinical trials are easier and can be done over the internet also. Paperless internet trials can be the future of Clinical Data Management. The advantages are that it keeps the paper behind and eliminates paper in trials, even in the doctor’s office. Also the savings from the Clinical Data Management are more than the use of paper. 

Today, even the IT industry is also entering the clinical trials market. The importance of Clinical Data Management is that you get fast data, correct data and electronic trials save paper. The best example of Clinical Data Management is Oracle’s Oracle Clinical. This application is used to set up and manage Clinical Data Management projects. There are many software tools that are capable of data management and they are called Clinical Data Management System. The common ones are Oracle, Macro, Rav, eClinical Suite and Clinical trial. 

Wednesday, 27 November 2013

Quality Clinical Data Management


Clinical data management also called as CDM is one of the crucial phases in clinical research. It helps to generate the reliable, high quality and statistically well data from clinical trials. It also helps to save the time that is used in drug development to the marketing. Right from inception to completion, the team members of CDM actively get involved in all stages of clinical trial to manage the data at a great extent. This member should have the sufficient and necessary knowledge that helps to maintain the quality standard of the process of CDM.

There are various processes in CDM. It includes database designing, case report form designing and annotation, data-entry, data validation, medical coding, data extraction, discrepancy management and database locking. During a trial all these processes are assessed to maintain the quality. However, a professional data management service can help to avail best quality clinical data management services for clinical trial, studies and research.

Spsoft offers the excellent and expert clinical data management services in India. The company implements the highly advanced technological solutions that provide reliable and accurate CDM services. Click here for the more information.

Wednesday, 16 October 2013

Clinical Data Management For Clinical Research & Studies

Clinical Data Management
  • Data management :- It is very important factors for various purposes. Especially, for the clinical research, the data plays a crucial role for conducting various studies and performing various treatments on patients. To manage important data, Clinical data management helps clinical research at great extent. It encompasses verification, entry, quality control and validation of the data gathered during the clinical trials.  
  • Role of Clinical data management in Clinical trials :- Today, Clinical data management is considered as a critical phase in clinical research. It generates statistically sound, reliable and high quality data from clinical trials. That means clinical data management plays a key role in conduct and set up clinical trials. Data collecting during the clinical trials helps pharmaceutical industry to develop a quality product. The clinical data manager involves in data collection option. He supervises the data collection tools that are based on clinical trial protocol. Once the enrollment of subject begins, the data manager ensures the important aspects of data such as collection, completion, validation and consistency. The manager also communicates with other data providers and ensures the safety during the data transmission and make sure the data is consistence with the other data in clinical trial. At the completion of clinical trial the data manager ensures that the all necessary data has been captured and then it is transferred to the statistical analysis.
Many clinical data management services in India provide quality clinical data management services to various clinical research and study. SpsoftIndia is one of the leading companies in India that provides global clinical data management services. The company offers expert clinical data management and a large array of services for clinical research and studies.  

Saturday, 5 October 2013

Clinical Data Management - A Best Way to Store Vital Health and Finance Information

Clinical Data Management
Clinical research trials produce a data which is used to test new technologies and pharmaceutical drugs.Clinical data management is one of the important branches of medical or clinical data management that verifies the data produced by clinical trials. 

Today, medical expertise and various branches of life sciences have reached at the level where they can research a smallest part of human body such as genes. While conducting such kinds of crucial medical trials, it becomes very necessary to collect the data systematically. Clinical data management along with the clinical research trial establish a strong base where the important information is obtain systematically and handed it over to the right person at the right time. The system of clinical data management helps to manage and monitor health information of patient. Therefore, it helps medical practioners to reduce immense manual work load and provide the details about subject and sample which are under the screening procedure in a single database. The clinical data management system is a professional way of organize the information that ultimately saves time and money.

Some of the major functionalities of clinical data management system:-
  • Storage of information in systematic and professional way.The information includes health and financial information about the patients.
  • Creation of case reports and protocols.
  • Monitor the data and determination of proper implementation of protocols.
Advantages of Clinical data management system:-
  • It reduce the workload.
  • It helps to save money and time.
  • Provide detail health and financial information about patient.
All in all, the clinical data management is a great way that store vital information in clinical trial of the patient.These data is used for the better treatment as well as in research.