Monday, February 15, 2010

eCollabora - Medical Writing

Introducing new drugs to the market is always an on-demanding scenario as drugs are the major influencing factors in healing any disease. With this never ending process, writing the clinical research documents has also become a high priority requirement for the sponsors.
Termed as Medical Writing ,this involves the process of drafting the entire trial data. And a good medical writing practice is that in which one focuses to document the clinical research data in accordance to regulatory compliances, design methodologies of the clinical trial and many more. Medical writing helps in understanding and documenting the trial specific data which is a major factor in clinical research process.
Maintaining the data quality while it is being drafted helps to ensure that a trial documentation is accurate enough as required. Data is expected to be drafted and maintained in an order such that it can be retrieved quickly when required especially in scenarios of regulatory inquiries.
Protocols, Investigator brochures , clinical Study Reports, Regulatory briefing documents , Manuscripts are some of the supporting documents for Regulatory Medical Writing.
Medical writing for the pharmaceutical industry are generally classified as Regulatory Medical Writing and Educational medical writing, wherein regulatory medical writing is intended in drafting the data for the approval of the drugs and devices.
CT Renaissance suite from MaxisIT has a regulatory compliant medical writing product named as eCollabora which takes care of end to end Medical writing needs related to a pirticurlar clinical trial.
Lets have a more insight into medical writing in terms of its types and advantages in the next article.

Sunday, February 7, 2010

Streamlining Clinical Trials through Regulatory Authority

Any clinical research is intended to have its prime focus on drug discovery, for which the process , procedures requires a plan of action , compliances , approvals and many more so as to ensure that the trial is under good clinical practices.

Regulatory Authority comes in place in the scenarios of approving, initiating, processing a clinical study. Its major concern lies in the principles that one need to follow in the clinical research. It is also intended over the appropriate qualifications, training and experience of the concerned Investigators of the trial.

Any clinical research conducted in any country has to be in lined with its country's respective regulatory authority from the start to end and till marketing the drug into general public.

To discuss the existing Regulatory Authorities of each country, DCGI- Drugs Controller General of India, FDA -Food and Drug Administration in USA, JMPA -Japan Pharmaceutical Manufacturers Association in Japan are some of the examples.

A related regulatory agency exists for each country where the sponsor wishes to sell the drug. It aims at reviewing all the submitted study data at each phase before the approval of the drug analysis to proceed to the next phase. There might be scenarios where a sponsor eliminates negative data, or misleads acquired data from clinical trials in which the regulatory agency may misinterpret the data. This can be handled in a different context, anyhow.

CT Renaissance, an end to end software from MaxisIT for clinical trials keeps a regular track of the regulatory activities and guidelines and ensures the software automatically is in compliance with the necessary guidelines and thus reduces the effort of cautiously monitoring the process if its in line with the regulatory guidelines in the respective geography

All related files of local site investigators after completion of a study are inspected in an audit, whether it is a planned audit or random, to check if study procedures were correctly applied. As we proceed further along with regulatory authorities, we read about Investigators, sponsors and many more. Let’s understand more into their roles, responsibilities in the later article.