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Global Standards of Quality Assurance in Clinical Trials

Clinical trials are conducted to collect relevant data for discovery of new drugs for curing or prevention of diseases. This data also helps academia, industry, and regulators to make crucial decisions about the safety and effectiveness of the disease or preventative medicines being studied. Clinical research project sponsors generally assign critical project responsibilities such as quality assurance to Contract Research Organizations or CROs.

Need for Quality Assurance (QA) in clinical trials

Quality assurance in clinical trials ensures that globally-accepted Good Clinical Practice (GCP) standards are followed to conduct the trials in a fair manner and high-quality data is collected.

CROs help project sponsors with the design of the protocol; project monitoring, report evaluation, and project documentation to be sent to the regulatory authorities for approval. The clinical research data has to be good enough for verification during audits and inspection by regulatory organizations.

The regulations are stringent for clinical research. India has some of the most trusted clinical research services offering superior quality assurance in clinical trials. For product approvals, the regulatory authorities have to be convinced that the clinical trials were conducted while protecting the safety and rights of the human subjects who were part of the trial.

Following are the leading global standards of quality assurance in clinical trials:

ICH

ICH has created an extensive range of safety guidelines. Clinical operation services follow these guidelines which were put forward to discover possible risks such as reprotoxicity, carcinogenicity and genotoxicity during trials.

FDA

FDA stands for Food and Drug Administration. It is one of the leading regulatory authorities that regulate scientific research focussed on new findings to develop new drugs. The aim of investigators who conduct these studies is to find out if the drugs being investigated are safe to use and can effectively solve the research problem. FDA ensures that confidentiality and safety is maintained in these clinical research studies

CFR

The CFR or Code of Federal Regulations by FDA needs to be followed by clinical research services to adhere to the compliance standards for drug development. The CFR codes are part of the Food, Drug, and Cosmetic Act for ethical production of safer products for end users.

ISO

International Standards Organization or ISO is an authority that has set global standards for various industries and is followed by a majority of nations across the world. For quality assurance in clinical trials, ISO 14155:2011 standard is followed today. The ISO certification is given to newly developed drugs that clear the ISO assessment. These assessments are conducted based on the national regulations and the nature of the clinical trial.

WHO

World Health Organization (WHO) has put forth GCP guidelines for various countries across the world. The content in these guidelines may vary from country to country but the pre-requisites for most countries remain the same. The purpose of these guidelines is again to establish scientific integrity and ethics in clinical research with human subjects.

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Why Pharmacovigilance is important in Clinical Trials?

Pharma companies produce the medicines to ease the pain of living beings on earth. Based on the medical solution that is required by the ones in pain, these companies use their trial population to conduct clinical research. India is one of the leading service providers of clinical research services in the world.

To ensure the safety of drugs for patients, pharmacovigilance services are utilised by the pharma companies in clinical trials for drug development. Here are some of the key reasons why pharmacovigilance services in India are important for clinical trials:

Safety Of Trial Participants

Clinical trials are conducted to determine the efficacy of a drug. And safety is the utmost concern for every clinical trial operation. Pharmacovigilance services support the project team to adhere to safety standards that protects the identity and well-being of the trial participants.

Stringent laws are present across the world to ensure safety in clinical trials. But ethical companies hire reliable support services to follow these laws as well as to encourage a fair trial for drug development.

Manage SAE

Safety Adverse Events (SAE) Reporting can be a time-consuming process but it is necessary as per regulatory authorities in many countries. These reports are created by pharmacovigilance companiesby collating data from various sources such as trial participants, regulatory resources, media reports, and other literature.

Risk Benefit Profile

The Adverse Event Reporting process also helps authorities and project sponsors to determine the risks and benefits involved in producing a drug. Clinical research professionals create a risk profile of the drug which includes its harmful effects, precautions for consumption, warnings etc. The benefits profile will list the therapeutic benefits of the drugs on the clinical trial population.

The risk benefit profile gives a clear picture of whether the risks outweigh the benefits or not. This profiling includes details of the trial participants, their response to the drugs, etc. Regulatory authorities look for a positive risk benefit profile with a balance between risks and benefits as per the guidelines.

Maintain Safety Records

Pharmacovigilance services in India are undertaken by well-qualified and experienced clinical research professionals. They not only help you to maintain safety records of all the small and big safety incidents but also help you in preventing similar safety lapses through insightful reports.

Case Safety Reports (CSR) are reports covering the adversity faced by each individual who was part of the trial as a participant. After the relevant data is used for the existing project, these reports are archived for future projects.

Project-specific Safety Approach

Every project is different in clinical research. India offers reputed CROs who deliver customised pharmacovigilance services. These services are designed taking in to consideration the project scope components such as project location, project team, participants, timelines, processes and so on.

Safety Adverse Events reporting is a critical step in drug development. Authorities study SAE reports and other drug development documents carefully. Service providers assist project sponsors by collating all the necessary documents that is to be sent for drug evaluation by authorities. And finally, the evaluation process will lead to the acceptance or rejection of the drug which will determine whether drug will be produced for the masses or send back to the lab for further research.

To conclude, pharmacovigilance services in India by reputed service providers such as BiosphereCRO, are a great help to conduct successful clinical research. Their expertise and understanding of the drug development process makes it easier for pharma companies to roll out useful drugs in the safest possible manner.

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Benefits of Clinical Research Services in India

The pharmaceutical industry in today’s times is reeling under the pressure of rising costs, stricter regulatory norms and shorter life cycles of products and is turning towards the Asian countries for conducting its clinical research studies. The existence of a strong intellectual base and low cost structure has made India one of the favourite destinations among the whole lot.

Clinical Research India Advantage

Clinical trials are needed to evaluate the efficacy of new medicines which work towards the betterment of patients. One of the popular global hubs for conducting these clinical trials is India and the reasons for the same can be listed as follows:

A progressive attitude and support of the Indian government

Availability of sufficiently sized patient pool

Presence of highly skilled and motivated medical and paramedical staff

Well-equipped hospitals

Strong information technology

Low-cost manufacturing abilities

Clinical Research Services in India- Enabling Clinical Trials to get off a Good Start

The drug development journey is a complex one and the requirements of regulatory compliance, sophisticated technologies and harmonized protocols can put a spoke in getting your drug to the market. Availability of clinical research services in India makes this task much simpler besides controlling the costs of development and reducing chances of late phase failure. The benefits of these services can be obtained all through the four phases of clinical trials starting from Phase I to Phase IV. Benefits at each phase are listed below.

Patient Recruitment

Forecasting, monitoring and managing patient recruitment is of utmost importance.

Offering a total scale of patient outreach.

On-site support assistance like training, data provision and any other.

Minimizing delays in the start of your clinical trial

Phase I Trials

Presence of testing units within the hospital offers immediate access to a state of the art environment for conducting Phase I safety studies.

High doctor to bed ratio & quality paramedical staff

Combination protocols

Target patients assured of safety studies

Pharmacological consulting services

Phase II-III Trials

Availability of skilled clinical team with wide experience in therapeutic area

Availability of comprehensive range of e-Clinical technologies (e-Prudent), technologies that enhance efficiencies, data accuracy and lead to cost reductions and speedier development times.

Application of best practices and proven measures of site management

Provision of customized and optimized clinical process

Phase IV Trials

Provision of supplementary information on the benefits, risks and best use of the drug after it gets the approval from the regulatory authority.

Summarizing

Clinical trials need to be undertaken using correct methods which comply with ethical considerations and Good Clinical Practice. This places a significant burden on medical institutions conducting clinical trials. Clinical research services provider offers dedicated support to biotechnology and pharmaceutical companies right through all stages of their clinical trials. The gambit of clinical operation services provided by the service provider includes the latest technology, the required infrastructure, knowledge and the experience needed to take the clinical trials to successful fruition.

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The Role of Quality Assurance in Clinical Trial

Clinical trials have to follow the ethical standards without compromising the quality of the trial results. The quality assurance teams take care of this critical area in clinical research. India has several clinical research companies who are able to deliver quality output to project sponsors by focusing on GCP(Good Clinical Practice) guidelines as per global standards.

Clinical trials are mostly expensive in nature. If there is a project delay or inadequate results emerge due to quality concerns, the project sponsor may have to spend more or lose all of it. That’s why quality assurance in clinical research cannot be overlooked. Quality issues can lead to legal issues or affect patient safety as well.

Incorporate QA in GCP for better clinical trials

GCPensures that the design, conduct, performance, monitoring, auditing, recording, analysis and reporting are managed in a fair manner.

Some of the QA-focussed clinical research good practices followed by CROs for clinical trial projects are:

Quality in Culture

If a culture of quality is imbibed in the project personnel then every project member handling different responsibilities, will keep an eye on the quality parameters. These professionals will work together as a single unit for implementation of quality assurance guidelines and make it easier for QA analysts to deliver higher number of quality trials.

Quality by Design (QbD)

The project sponsor and the Clinical Research Organisation (CRO) should together design the project in such a way that each step of the clinical trial process has a quality check component. There should be enough QA checks to ensure that error don’t go too far unnoticed. Because, the longer it takes to spot an error, higher are the impacts on the safety and efficacy analysis of the clinical trial.

Quality as per regulatory requirements

The clinical trials have to be conducted in accordance with the guidelines set by global and local regulatory authorities at the trial location. The CRO should be aware of all these regulatory limitations and communicate all the challenges in this respect to the sponsor. This is necessary for avoiding any issues in running quality trials once the project is in the implementation stage.

Quality to respect the trial subject

Clinical trials are conducted on subjects who have to meet specific parameters for ensuring their suitability in trial participation. The quality assurance for clinical trials also takes up the responsibility to get protocol compliant subjects for the project. But these subjects have to be treated with utmost respect and should be treated within the limits of ethics.

Quality Audits

In clinical trials, audit teams run audits for protocols, SOPs, ICH/GCP guidelines and other nation-specific guidelines such as EU Clinical Trial Directives, etc. It is the duty of the audit team to run internal audits during the drug development process, review documented trial data, etc.

As part of quality assurance for clinical research, the audit team performs audits right from the initial data collection stage to the final trial report stage. These audits help the project team members to review the entire clinical trial process; rectify issues on time; and improvise the processes for future trials.

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To discuss more about quality assurance in clinical research you can contact Biosphere, a reputed CRO by contacting +91 9029025200.

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Benefits and Risks of Clinical Trials

Today, medical research has become one of the important components contributing to the Indian economy. Further, it is a significant field of study which helps towards providing advanced medical treatments and cure. Both public as well as private sectors are included when it comes to developments in the medical research field.

In the recent years, India has seen tremendous progress in the field of technology and science with several multinational pharmaceutical firms planning to launch themselves in India and initiate many research programs in the country. The Government of India has always offered its support as well as guidance towards the progress and development of these research endeavors. Due to this it has become immensely important to effectively explore the authenticity of the treatment, medical strategy and equipment.

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Clinical Operation Services

Clinical operation service is one of the most crucial aspects of the clinical research.The Clinical Operations is the key process for the delivery of clinical trials. Without Clinical Operations Clinical Research activity could never be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials.

Tailored solutions are designed by the experts in conjugation with the clients to get the appropriate output within stipulated time and budget.

Remote Monitoring of Clinical Trials

Remote monitoring for clinical trials is very important, as it offers real-time management of data along with the proficient monitoring procedure. It is an online system that allows the professionals to access the data with ease. Once the data is fed in the system, it can be accessed by everyone to avail the optimum benefits. Integrity is maintained while collecting and maintaining the data, as this paves an appropriate path for the systematic clinical trial.

RSM allows monitoring activities which were previously conducted on-site to be conducted remotely, increasing efficiency and speeding up time to market. The CRA does not spend time onsite, instead the CRA performs all the study monitoring processes remotely, using a secure online platform.

The major benefit of Remote Site Monitoring (RSM) is that the CRA indeed spends much less time, if any, at the clinical sites. When you consider that an average of 30% of the total clinical study budget is spent on CRA sites visits, it is easy to understand that RSM are quickly becoming key elements of the global study process.

Why Clinical Trial?

Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.

Although “new” may imply “better,” it is not known whether the potential medical treatment offers benefit to patients until clinical research on that treatment is complete. Clinical trials are an integral part of new product discovery and development and are required by the Food and Drug Administration before a new product can be brought to the market.

Benefits of the Clinical Trials

Let’s check the benefits offered by the method of a clinical trial:

Access to promising new treatments often not available outside the clinical-trial setting

Treatment that may be more effective than the standard approach

Close monitoring, advice, care, and support by a research team of doctors and other health care professionals who understand your disease or condition

The opportunity to be the first to benefit from a new method under study

The chance to play an active role in your own health care and gain a greater understanding of your disease or condition

The chance to help society by contributing to medical research. Even if you don’t directly benefit from the results of the clinical trial you take part in, the information gathered can help others and adds to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care.

Risks involved in the Process of Clinical Trial

Along with the numerous benefits, clinical trials also involve various risks. Let’s have a look at those:

It demands frequent visits to the lab than the non-clinical trials.

Doctors can ask to stay at the hospital for close monitoring.

There might be some serious side-effects of the trial method that can be life-threatening.

The experiment might work for some but there are chances that it won’t work for a few of the people.

Conclusion

Clinical research in India is improving with the help of the latest technologies, government facilities and improved regulations / framework.

Clinical research has opened up many lucrative job and business prospects in Clinical Operations, Medical writings, CDM, Pharmacovigilance.

Capable professionals are getting an opportunity to showcase their talent in the field of research with an aim to serve the mankind in a better way.

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Importance of Remote Monitoring in Clinical Trials

The scenario of clinical research studies is becoming more complex in view of the ever increasing regulatory compliance demands, increased intricacies and the increasing costs of conducting research. If these constraints have to be tackled then technological optimization is a must. Organizations are more interested in meeting up with the rising costs and deadlines on one hand and ensuring patient safety and regulatory compliances on the other. This has led to the increased importance of remote monitoring for clinical trials.

What is Remote-Based Monitoring in Clinical Trials & How It Works?

Remote-based monitoring is an approach where clinical professionals are not needed to visit the research clinic physically for monitoring purposes; instead they review the data remotely through secure online workspaces. Reviewing data through one such platform like Intralinks VIA is highly useful in this context. Protocol is executed by the research clinics in the normal manner and additionally data is entered in the eCRFs (electronic case report forms). All source documents, medical, labs histories and documents including informed consent forms and the like are uploaded to the secured online workstation. The data can be immediately accessed by the clinical research associate (CRA) and the notification of the same is received by the research clinic.

Once the data is uploaded the CRA compares the source document data with that included on the eCRF and this becomes his ‘monitoring visit’. As the verification of the source data is conducted remotely, this is termed as remote-based monitoring.

Importance of Remote Monitoring for Clinical Trials

Utilizing a partner that provides clinical research services is a must for conducting smooth, hassle-free and successful clinical trials. Among the many services offered, remote-based monitoring is gaining increasing importance because of the several advantages obtained through it.

Effective Collaboration: Remote monitoring facilitates effective collaboration between the sponsors and the clinical research associates with respect to finalizing documents during the site initiation process.

Time Saving:Significantly reduces time taken by research clinics to start screening the study participants

Cost Effective: Site visits may not always be feasible or they can be very costly. In this approach, time if any, needed to be spent by the clinical research associate at the clinical siteis drastically reduced, consequently reducing the budget allocation for the same.

Patient Centric: Highly useful in monitoring patients afflicted with chronic diseases like diabetes as they are not required to be confined to the clinical environment all the time. With patient centricity being the current trend this approach is very favourable.

Focus on Core Study: Clinical research staff and associates find more time to concentrate on the core study rather than restricting themselves on operational checks.

Patient Availability:  One of the tiresome processes of clinical research is patient recruitment. Patient dropout which is normally linked to travel inconveniences is another aspect that can affect the successful completion of a clinical trial. Remote based monitoring maximises availability of patients and enrolments in clinical research studies and reduces incidences of patient dropouts too.

Data Quality: Access to data is immediate and transfer of data is most secure. This promotes data quality and brings the element of quality assurance in clinical trials.

Summarizing

Notwithstanding the challenges, remote-based monitoring has made a lot of positive contribution to clinical trials.