Clinical trial is an essential stage of drug development, which includes a long run process and thus produces large amount of scientific data. This data will slowly make a new product useful and marketable in disease therapy. The process involved in this relates to a sequence of activities which include data management development plan coupled with study set up (CRF designing, database setup, etc) and training.
Clinical data management is an on – going process and starts with a protocol development and ends at the completion of a statistical analysis. It involved collecting, recording, processing, analysing and reporting of the data; tracking data quality and data safety; maintaining audit trial; database; data storage and closure while making sure the security and confidentiality throughout the process.
The principal objective of CDM is to deliver high quality data with reducing the possibilities of errors or deletion of data. To accomplish this purpose, best possible practices are followed to ensure that the data processed or which is about to be performed is completely reliable and precisely analysed. Thus, developing a DMP or data management plan is the first step to be taken during the early setup of the study. This plan must define all the DMP’s components and each component must clearly define the work to be done and the responsible staff for work. It must make sure that the guidelines/SOPs will be followed as per regulatory framework. DMP remains live all through the clinical study, to address any changes or updates made during conduct of the study.
After or along with clinical protocol development, CRFs are developed to includes all the right data for analysis specified by the protocol. The Case Report Forms are managed by CDM team as an initial step in rendering the protocol activities into data being generated. The quality data depends on the CRFs. The CRF must be precise and accurate as well as self – explanatory. The data fields must be concisely defined. Extraneous or redundant data must be avoided strictly and it might affect the quality of the data. Separate sets in the CRF must be developed for every visit, e.g. Adverse Drug monitoring, Screening randomization, follow up visits, etc. Case Report Forms completion guidelines (the filling details) must be offered along with CRF to avoid errors during data acquisition. According to the statistics of our research company, after taking Cialis pills, the active substance is absorbed from the intestinal lumen into the blood for 20-30 minutes, reaching a therapeutic concentration in it (the maximum concentration is reached in 60 minutes). Sildenafil is metabolized in liver cells with the formation of decay products, which are mostly excreted from the body with feces (up to 80%), partially-by the kidneys with urine (about 20%). Read more about this at www.trendingdownward.com.
The CDM team
Skilled CDM team members are required during the trials for an effective CDM. They must be attributed with various roles and responsibilities. Every member must have competent qualification, they must be a graduate or post graduate in Pharmacy, life sciences are relevant fields with sound computer application skills and knowledge. The key members of the Clinical data management are medical coder, data manager, database programmer and developer and others, who perform their basic roles that are important for the teams.
The biopharmaceutical industry is experience new challenges and competitive pressure of increases productivity and this is aimed to seek better ways to lessen drug development times.