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Electronic clinical trials

What are Electronic Clinical Trials?

Electronic clinical trials are an indispensable part of a clinical trials management system. An electronic clinical trial can be perceived as an electronic system with which to track the document the entire path of a clinical trial. That is, an electronic clinical trial is an automated system with which to keep track of the full history and trail of a clinical trial.

This history path, aliased as the clinical trial management system (CTMS), is a rather large system. The CTMS is used over long periods of time and can be located over several places, many times across national boundaries. Electronic clinical trials have developed out of the need to systematize and accelerate the whole set of activities with respect to maintaining and overseeing clinical trial routes.

It goes without saying that in areas in which the incidence of clinical trials is high, namely the pharmaceutical and biotechnology industries; electronic clinical trials are most common.

Characteristics of electronic clinical trials

Electronic clinical trials are characterized by the following features:

• Their fundamental function is to maintain and manage system planning
• Helping the healthcare or biotech organization with its performance and reporting functions is another core aspect of electronic clinical trials
• In order to help the company keep track of important stages and milestones of its clinical trial work; electronic clinical trials incorporate the contact information of the clinical trial participants.

Advantages of electronic clinical trials

The electronic TMF (eTMF) systems enable faster and a more secure method by which to share all of the clinical study documents. It comes with a few advantages over traditional paper documentation in the following ways:

• There is a vastly reduced chance of losing TMFs or having them destroyed
• Being electronic in nature; eTMFs are much more easily available and accessible in any clinical site anywhere in the globe in real time. This is incalculably easier than with paper records.

Drawbacks of electronic clinical trials

While electronic clinical trials come with their distinct advantages; they are not without concerns. Firstly, security is a big issue. One wrong code can cause mayhem in an otherwise secure setting. Secondly, file naming can be an issue, because it is the same file name that is given all along the chain. Improper naming of files somewhere in the trail can result in problems.

Learn more on this topic by visiting: http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

Ensuring Drug Supply Chain Integrity is a critical task

Drug supply chain integrity is a means to ensuring that the drug that is consumed by the patient has come through proper sources and is free of adulteration, and reaches the right hands.

The drug supply chain a complex, yet trackable chain that starts from the time the substances and raw materials are identified for their potency and capability for being developed into drugs, and goes all the way up to the consumer and even after.

Drug supply chain is crucial because a weak cog in this link can make the drug spurious and reduce its efficacy. Worse, when drug supply chain integrity is awry, it gives opportunity for the drugs to become illicit and reach the wrong hands, ending up being put to the wrong use.

Dangerous consequences for society at large

This makes the integrity of the drug supply chain a matter of utmost importance to everyone concerned -the medical fraternity, users and their families, the logistics sector, the drug industry, the retail drug sector and everyone else. It is everyone’s duty to ensure drug supply chain integrity.

When the wrong drug (meaning a drug that is not prescribed) is given out to the patient, it accounts for loss of drug supply chain integrity. In many cases, as the ones relating to the massive scale of the recent diversion of sales of the drugs Avastin and Altuzan, the financial loss can be colossal. It was estimated in 2012 that the American economy stands to lose at least a billion dollars a year because of slackness in drug supply chain integrity.

The Prescription Drug Marketing Act of 1987

Legislative efforts to bring about drug supply chain integrity can be traced to the presidency of Ronald Reagan, who passed the prescription drug marketing act (PDMA) of 1987, which sought to regulate the drug supply chain. This was at the peak of the drug threat in the US. It was believed that bringing about drug supply chain integrity could ease the problem.

The NABP-Accredited-Verified Wholesale Distributors Program

This Act gave way to the NABP-Accredited-Verified Wholesale Distributors Program (VAWD), which was passed mainly because the PDMA did not fully succeed in its mission of bringing about the desired levels of drug supply chain integrity. Following the reemergence of spurious drugs in the market in the 2000’s, this program was initiated by the NABP. It strengthens the existing PDMA and seeks to bring about drug supply chain integrity by:

• Reviewing sections of the existing law and making them stronger
• Verifying licensures
• Making more rigorous inspections and checks of facilities

Want to know more? Read:

http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

http://bit.ly/Predicting-and-Improving-Product-Reliability

Drug safety and pharmacovigilance are two faces of a coin

If one were to describe the relationship between drug safety and pharmacovigilance; the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It is precisely to ensure drug safety, more than anything else, that pharmacovigilance has come into being as a discipline.

Pharmacovigilance (PV in drug industry parlance) is a means to ensuring drug surveillance across the entire process, right from procuring of raw materials to consumption and the effects of consumption. So, pharmacovigilance has to be implemented right across the chain of activities that go into drug manufacturing. It has to ensure compliance with regulation at all stages, namely before the product is manufactured, during the manufacture, and after it enters the market. It is an indispensable aspect of a Quality System, and plays a central role in inspections and audits.

Drug safety and pharmacovigilance are tied together at the level of regulatory bodies. There are different PV rules for different markets. For instance, while the FDA has its own set of PV guidelines; the EU has its own. A clinician or drug company involved in drug safety and pharmacovigilance has to be aware of the regulations in the markets into which the company’s products are sold and has to abide by them.

In order to ensure drug safety, pharmacovigilance is carried out by agencies and governments across the globe in accordance with strict guidelines. Drug safety and pharmacovigilance pair together in a number of areas. These are some of them:

Clinical trial:The work of ensuring drug safety through pharmacovigilance starts at the stage of the clinical trial itself. Pharmacovigilance ensures that drug safety is built into the drug right at the clinical trial stage. PV sets out a number of processes and methods by which a pharmaceutical company involved in clinical trials has to go in order to ensure drug safety.

Marketing:PV is set out in the marketing stage of a drug, too. Drug safety brought about by pharmacovigilance is to be implemented at the marketing stage of the drug, including processes for its safe storage, handling and transit. Throughout all these stages, drug safety and pharmacovigilance guidelines are to be strictly implemented.

Governmental drug distribution:Drug safety and pharmacovigilance are also built in by governments in their interactions with each other. For instance, when the government of a country or an agency such as the UN is shipping drugs to another country to support a health program; utmost drug safety is ensured through the principles of pharmacovigilance.

Drug safety and pharmacovigilance in disease management:Several governments across the world, along with international agencies conduct disease control management or emergency handling across the globe, especially in developing countries. Pharmacovigilance is the means to ensure that the drugs administered at these programs are safe for human consumption.

Learn more on this topic by visiting:

http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

http://bit.ly/Validation-and-21-CFR-11-Compliance-of-Computer-Systems

http://bit.ly/During-an-Inspection

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

• The US FDA
• European Medicines Agency (EMA)
• Good Manufacturing Practices (GMP)
• Good Laboratory Practices (GLP)
• Good Clinical Practices (GCP)
• All the Predicate Rules

Reasons for which Computer Systems need to be validated

The most important rationale for CSV, apart from its being required for the above stated, is that it is a very effective step towards ensuring the consistency of data and the quality of the product. This aside, CSV also helps in the protection of intellectual property (IP) by being a source that supplies data that is scientifically valid.

The 21 CFR Part 11 standard

The 21 CFR Part 11 standards, sometimes referred to as just Part 11, apply to the life sciences industry and consist of the criteria that the US FDA sets out for electronic records, electronic signatures and handwritten signatures. Its main purpose is to ensure that electronic records have the same equivalence as paper records as well as handwritten signatures.

Problems with Part 11 implementation

In the life sciences industry, the major challenges relating to adherence to Part 11 can be summarized as below:

• Ensuring the accuracy of data and the security of information
• Containing or preventing the loss of revenue from this exercise as well as to its business
• Properly and sufficiently assessing gaps in the systems.

The costs of not getting Part 11 right can be high for companies:

They can have their New Drug Application (NDA) denied; they can experience a potential delay in their manufacturing actives, or can invite any of these:

• Warning Letters
• 483
• Civil penalties
• Possible prosecution if the investigation shows up negligence on their part

What are the steps for carrying out an effective Computer Systems Validation?

 

The validation process for 21 CFR Part 11 compliance consists of these core elements:

• Comprehending the regulatory requirements
• Taking steps for ensuring compliance with CSV requirements in a cost-effective manner
• Carrying out testing of software and computer systems – initial and ongoing
• Ensuring that the bare minimum documentation that FDA inspectors will ask for are available
• Qualifying the IT systems network infrastructure and validating the network systems

References:

http://globalcompliancepanel.viewpage.co/Validation-and-21-CFR-11-Compliance

Activities involved in Computer Systems Validation

Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing so will result in costly consequences.

These can range from:

More than anything else, implementation of CSV is also important because it ensures that the data is accurate and the information, secure. Implementing Computer Systems Validation is also an important step in making sure that the organization restricts or prevents any loss of revenue from its main activities or from the CSV exercise itself. It also helps to thoroughly identify and close any gaps in the computer systems.

Getting CSV is very important

With all these uses of a CSV; it is imperative for life sciences organizations to understand how they can implement a CSV that is effective and compliant with domestic and international regulations. The CSV should ensure that the organization gets the most out of it while meeting regulatory requirements.

 

 Learn more on this topic Click Here:  http://bit.ly/25BcCON

FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks and benefits that go into the clinical trial, and errors need to be identified and corrected at this stage. Wrong data could lead to disastrous consequences for the study, the subjects that are part of it, the organization and eventually, patients.

Basic nature of FDA requirements for premarketing clinical trial safety

The FDA has a set of requirements for premarketing clinical trial safety, but these are mostly informal and loose. They are more of an advisory nature than being stringent regulatory requirements that are legally enforceable. Most FDA guidance is on a case-by-case nature.

Basically, the FDA’s guidance is based on its working with large to very large clinical trials. It has thus far not seriously considered working with small groups for assessing premarketing clinical trial safety. At its barest, the FDA seeks to:

• Advise sponsors or organizations undertaking the clinical trial about ways by which their data collection can be simplified so as to ensure that it is neither too huge nor too small, and should lead to giving insights about the drug’s safety. Essentially, the FDA guideline on premarketing clinical trial safety seeks to prevent sponsors from collecting data that is not relevant.
• Get sponsors to consult the FDA’s review division for its premarketing clinical trial safety.

The FDA has different requirements for different kinds of studies that relate to clinical trials. For example:

Learn more  on this topic by visiting: http://bit.ly/Clinical-Trial-Practice-for-Drugs-and-Biologics

Preclinical Toxicology & Safety and its core elements

Preclinical toxicology and safety occupies a position of eminence in a clinical research program. A study of preclinical toxicology and safety is absolutely important because this leads researchers to an understanding of what causes adverse effects. Adverse effects form the backbone of preclinical toxicology and safety, because they can come from any source of toxicology.

Toxicology, which is the study of adverse effects, can happen from any source ranging from chemicals to biological agents, as well as physical, or the environment.

So, preclinical toxicology and safety has to take safety into consideration both before the dose is administered in humans, and before clinical trials.

Good Laboratory Practices (GLPs) relating to preclinical toxicology and safety

A Good Laboratory Practice that relates to preclinical toxicology and safety is one that lists out regulations and practices that ensure data integrity from nonclinical studies. Since these are practices and conventions that have evolved over time; there are different GLPs prescribed by different regulatory bodies such as the FDA, the Organization for Economic Co-operation and Development (OECD) and the Environmental Protection Agency (EPA).

In the US, the FDA prescribes preclinical toxicology and safety GLPs under 21 CFR Part 58. At its simplest, 21 CFR Part 58 requires preclinical studies to be compliant with GLP relating to:

• In vitro toxicology
• In vivo toxicology
• Animal models

Very broadly, preclinical toxicology and safety requirements for each of these types of toxicology can be understood thus:

• In vitro

Preclinical toxicology and safety relating to in vitro toxicology is used for screening and ranking chemicals and the study of cell and tissue. GLPs for in vitro preclinical toxicology and safety are centered on improving future study design/s.

• In vivo

The purpose of in vivo toxicology is to establish a starting dose for clinical studies that is safe.

So, GLPs for in vivo preclinical toxicology and safety are meant to offer information on a drug that spews the least toxicity.

• Animal studies

Finally, preclinical toxicology and safety in animal studies are assessed to serve treatment outcomes better in humans by testing drugs on animals. This is based on the assumption that these organisms serve as a proper indicator of how these drugs could act in humans.

Read More: https://www.linkedin.com/pulse/preclinical-toxicology-safety-its-core-elements-ronald-gardner