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.

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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.

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Checklist for preparing a Statistical Analysis Plan for Clinical Trials

Checklist for preparing a Statistical Analysis Plan for Clinical Trials...

• Provide a detailed description of the primary and secondary endpoints and how they are to be measured.
• Provide details of the statistical methods and tests that will be used to analyze the endpoints. The analysis of the primary outcome must follow the principle of intention-to-treat.
• Describe the strategy to be used (e.g., alternative statistical procedures) if the distributional or test assumptions are not satisfied.
• Detail whether comparisons will be one-tailed or two-tailed (with appropriate justification if necessary) and specify the level of significance to be used.
• Identify whether any adjustment to the significance level or the final P values will be made to account for any planned or unplanned multiple testing or subgroup analyses.
• Specify potential adjusted analyses with a statement of which covariates or factors will be included.
• Identify any planned subgroup or subset analysis along with justification for the relevance of this analysis (eg, biological rationale) before commencement of the trial.
• Specify planned exploratory analyses, justifying their importance.
• Support claimed differential subgroup effects with biological rationale and supporting evidence from within and outside the study.
• Provide statistical evidence of interaction between the overall treatment effect and that observed in the subgroup(s) of interest.
• Remember that pre-specified subgroups will have more interpretive value than those defined on an ad-hoc basis or as a result of multiple comparisons.

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Renaissance in Clinical Trials

As discussed in the previous article, the clinical trials industry today is in a rapid transition phase. As there has been a move from paper based to computer based system, there is an another era that clinical trials industry is all set to witness. Renaissance in Clinical trials is the buzz word.

This renaissance in clinical trials has anounced its arrival on the clinical world scenario by bagging the Bio-IT World, Best of the show award and is set to achieve much more and revolutionize the clinical trials process, by reducing the cost, time of study, at the same time assuring the safety and efficacy of the drug.

This renaissance of clinical trials which is set to revolutionize the clinical trials is the product named CT Renaissance from the brians of MaxisIT, which is a pioneer solution provider in the clinical trials industry. With CT Renaissance in hand the clients, customers or Sponsors,CRO can focus on the other aspects of the Clinical Trials leveraging the software needs on CT Renaissance. This ensured a complete success of the clinical study

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Clinical Trials: Paper Based to Computer Based What next???

Clinical Trials Industry today is in Transition Phase. It has moved out from traditional paper based approach of conducting clinical trials to the electronic ways to conducting clinical trials. Paper based was good old convenient procedure that was in place right from the origin of Clinical Trials till last 5 years ago.

As the world, people, technology are under contant change, and it is believed that change is for good, Clinical Trials industry has also witnessed change. Paper based Clinical Trials were tedious, taking 15 long years of time for the completion of a study, there was always a commotion about roles and responsibilities, documentation, submissions and approval process.

During the paper based clinical trials, regulatory authorities did not have proper guidelines in place, hence the data bieng submitted by the sponsor was tough to interpret for the regulatory authorities and thus taking a long period of time for the approval of the drug. There was every chance of duplicating the documents, Information Security was the biggest concern

Slowly independent Computer softwares, which address, automate a part of the clinical trials process have started ruling the space left by paper based clinical trials. There were also certain standards and guidelines prepared by the regulatory authorities, which every clinical study needs to be in compliance with.

With the emergence of these independent software solutions, certain areas of the clinical trials were speeded up and also reliability was a good success with these systems. There was a sense of success all around, but this has not addressed all the needs of the clinical trials softwares. Is there anything available beyond this?

Where is the clinical trials Software Industry heading to? Is the industry set to see something which can redefine the process of clinical trials? Please add your views regarding this interesting discussion...

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