Uses of the Clinical Trial Management System

Posted by sleepyguy in Prescription Sleep Medicine on November 08th, 2009

Pharmaceutical and biotechnology companies spend thousands of dollars and a considerable amount of man hours on clinical trials of drugs before they are launched in the market. These involves the use of humans to test the efficacy and hazards of a new drug.

Clinical trials are very elaborate procedures that are monitored by stringent regulations. The efficient management of them requires the use of a reliable CTMS that helps scientist monitor the clinical trials, analyze data, report to regulatory bodies and study the effectiveness and adverse effects of the drugs.

CTMS is a computerized system of data management which allows drug manufacturers to collect and organize data from clinical trials. With the CTMS, pharmaceutical firms can:

  • Collect, store and organize clinical data
  • Assess the efficacy of drugs using stored data
  • Research adverse effects using clinical data
  • Monitor budgeting
  • Handle patient management
  • Verify compliance of trial procedures with government regulations
  • Work simultaneously with other systems such as data management systems, electronic data capture, and adverse event reporting systems.
  • Manage the manufacture and marketing of medicines after launch

CTMS is an indispensible tool to any pharmaceutical or biotechnology company. These systems help save on the time taken to organize and store data. Everyday is vital for a company, as there are thousands of patients waiting for a cure. Drug manufacturing is a very competitive industry; there are so many companies working on the same lines. The faster a pharmaceutical company comes out with a new cure, the sooner it can get the drug patented and the more income it can generate.

CTMS cuts down on administrative costs, helps access valuable data instantly and helps monitor compliance of trials to regulatory standards. Confidentiality is very important during trials. With a centralized access system, the data is kept secure. But most importantly, the system helps ensure the safety of drugs that are under trial.

Medical science has grown in leaps and bounds since the days of Hippocrates. Modern day pharmaceutical drugs are really life-savers. They have increased life expectancy and improved the quality of life for millions of people. But there is the other side of the coin as well. These drugs sometimes have very adverse effects that can even be life-threatening. The drug Vioxx is a case in point.

What is pharmacovigilance?

There is a need to monitor the effects of drugs before and after it’s successfully tested and launched in the market. Pharmacovigilance involves monitoring and assessing the quality of drugs; detecting and preventing any adverse effects of drugs. Pharmacovigilance involves evaluating information provided by healthcare providers, pharmaceutical companies and patients in order to understand the risks and benefits involved with a particular drug.

What is the role of pharmacovigilance?

The goal of pharmacovigilance is to:

  • Monitor the quality of drugs
  • Identify the health risks involved in the administration of certain drugs
  • Prevent harm to patients
  • Research the efficacy of drugs

How does pharmacovigilance help the public?

Pharmacovigilance helps save thousands of lives each year. By monitoring the adverse effects of drugs right from the lab to the pharmacy and then on for many years, pharmacovigilance keeps track of any drastic effects of drugs. This way, it prevents harm to patients using those drugs.

?How does pharmacovigilance help drug manufacturers?

Pharmaceutical companies spend millions of dollars and a considerably long-time in developing new drugs. They again spend a lot of money in conducting clinical trials before the drugs are approved and launched in the market. But after all this, if there are adverse effects to the drugs, the company again loses millions of dollars in sales and litigations. Furthermore, the reputation of the company is also severely damaged. Pharmacovigilance monitors the development of the drug across various stages and assesses its effectiveness after its launch for many years. This way it may reduce the adverse risk from drugs, thereby aiding the drug manufacturers.

Alternative Medicines - Do They Work?

Posted by sleepyguy in Prescription Sleep Medicine on November 08th, 2009

There are many different alternative medicines on the market at this time. They all promise great results, such as colloidal silver and colloidal gold. There are also herbal remedies. Do these things work? Let us take a look.

With so many claims about alternative medicines, you may wonder whether they really work. After all, if they really worked, wouldn’t doctors be using the silver water, and dandelion?

The answer needs a bit of investigation. For most of mans history, the use of holistic medicines was the main route to healing.

However, science decided to take a turn in the late 1800’s and it has gone on to 2000. That is over 100 years, science didn’t hold holistic methods as a reliable healing method or is it?

Only recently has medicine started showing its support for holistic practices. For example, some doctors are offering holistic medicines.

The main reason for the change is the pharmacy companies can’t really patent a readily available holistic blend of ingredients. So even if it works better, pharmacy companies would never provide the holistic version. This applies to all different industries. For example, Coca Cola would never tell you the formula, even though it is literally sugar, water, and some other ingredients.

As such, it is now a time of empowerment. People are reporting great and beneficial results with the right alternative medicines. For example - silver water has had rave reviews.

Some people who really want the healing, and do more than just trusting a doctor, and actually go out and find a solution, usually find some great solutions which work.


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