Quality in Clinical Trials
After all the complaining that "quality" is not great in Indian CRO's we often miss the whole poing about quality. Lets break this discussion into two levels : 1. How is quality measured, 2. How to improve quality in your clinical trials ?Quality in clinical trials is a product of reliability & credibility and compliance to the protocol/process specified by sponsor/client. The customer or client is looking at fulfilling requirements such as : budget, legal regulations, ethical guidelines, study protocol, time frame and GXP. Most of the large MNCs have Quality Management Systems (QMS) toestablish and consistently achieve quality objectives. QMS are structured into training, SOP/procedures, Quality Control and Quality Assurance.Procedures and SOPs can be specific to a sponsor or to an investigator site. SOPs clearly define the timeframe, specifications of input and output and most importantly the role of each team member. They also serve as tools for training and for change management.Quality control : systematic checks on the compliance of the trial process & reliability and credibility of dataQuality Assurance : independent audits of all trial-related processess & functions. Can be trial or project specific or system audits.
Showing posts with label clinical data management. Show all posts
Showing posts with label clinical data management. Show all posts
Tuesday, August 5, 2008
Drug Safety and Pharmacovigilance
The ground truth of how pharmaceutical industry has evolved over the past decade is the large surge in increased specialization and sophistication. In this series we will focus on specialist careers in pharmaceutical industry, lets start with pharmacovigilance.
No medicine which is effective is 100% safe, but the adverse/side effects of a drug have to be weighed against the benefits of the drug. For example a drug treating terminal disease like cancer can have some adverse effects like vomiting and hair loss, but still it would be approved given the gravity of disease it is used to treat. Drug safety function focuses on measurement, prediction, reporting and evaluating safety signals. There are several roles in this domain namely :
Drug safety physician
Safety specialist
Safety informatics expert
Safety information expert If you are good at either synthesising medical information/research finding or have great analytical capabilities to drill down into complex safety data this area of specialization is very suitable and lucrative for you.
The ground truth of how pharmaceutical industry has evolved over the past decade is the large surge in increased specialization and sophistication. In this series we will focus on specialist careers in pharmaceutical industry, lets start with pharmacovigilance.
No medicine which is effective is 100% safe, but the adverse/side effects of a drug have to be weighed against the benefits of the drug. For example a drug treating terminal disease like cancer can have some adverse effects like vomiting and hair loss, but still it would be approved given the gravity of disease it is used to treat. Drug safety function focuses on measurement, prediction, reporting and evaluating safety signals. There are several roles in this domain namely :
Drug safety physician
Safety specialist
Safety informatics expert
Safety information expert If you are good at either synthesising medical information/research finding or have great analytical capabilities to drill down into complex safety data this area of specialization is very suitable and lucrative for you.
Certified Clinical Data Manager (CCDM) Certification
If you are keen on a career in CDM you should seriously consider CCDM certification exam. You will find the details on the exam at this link SCDM websiteHowever this exam is not an easy one, we will do a series of post discussing how to get certified and what you need to learn for this exam.The very basic knowledge you need is how clinical process work, mainly the phases in clinical research and what happens in each phase of drug development. The key aspect is that you should understand how data is collected and what data is important and the relevance of quality of the data you deal with. Also you should be familiar with regulatory and other guidelines such as GCP, ICH guidelines. For example knowledge of 21 CFR Part 11 is critical.
If you are keen on a career in CDM you should seriously consider CCDM certification exam. You will find the details on the exam at this link SCDM websiteHowever this exam is not an easy one, we will do a series of post discussing how to get certified and what you need to learn for this exam.The very basic knowledge you need is how clinical process work, mainly the phases in clinical research and what happens in each phase of drug development. The key aspect is that you should understand how data is collected and what data is important and the relevance of quality of the data you deal with. Also you should be familiar with regulatory and other guidelines such as GCP, ICH guidelines. For example knowledge of 21 CFR Part 11 is critical.
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