The clinical trial environment in India witnessed a downfall in 2013 following below-mentioned concerns around the conduct and continuation of clinical trials in India after a series of unfortunate incidents:

• The death of 2,644 volunteers during clinical trials over the preceding seven years.
• A Public Interest Litigation petition filed in 2012 on behalf of the NGO Swasthya Adhikar Manch (SAM) that sought justice for drug trial victims throughout the nation, asking for a ban the conduct of clinical trials in India for new products that will not be sold or marketed in India.
• Consequently, halting of 162 trials from global pharma companies.

As a result, the Supreme Court asked the Drug Controller General of India (DCGI) for details on the mechanism adopted to approve the trials. This propelled the government to make some changes in the regulatory framework regarding clinical trials, such as the online review process was extended with added liability for sponsors along with constraints on trial numbers per investigator and required sizes of sites. With the improved regulations setting in to reduce approval time and increase harmonization, India could soon be able to encourage a patient-friendly environment for clinical trials in the near future.

Improvement in Indian Regulatory Environment Over the Years:

There have been constant updates to policy and guidelines governing the conduct of clinical research in India in the past few years. The fundamental objective of these updates was to give topmost priority to patient safety in an overall difficult regulatory environment. However, Indian regulations have seen positive development in the recent past to favorably support clinical research, while simultaneously focusing on patient safety. These regulatory changes will facilitate the entry of newer innovative medicines to Indian patients at the earliest:

• Three tier review process for clinical trial applications (By SEC Meeting, Technical Committee, and Apex Committee)
• Mandatory registration of ethics committees with DCGI
• Compensation and free medical management (In case of trial-related injury or death)
• Audio-Video recording of Informed Consent process
• Tougher requirements for site selection
• Regulatory inspections
• A comprehensive policy and guidelines for all aspects related to approval of new drugs and clinical trials (originated as a result of a setback received by the industry in 2012-13)

In addition, other regulatory updates suggest that academicians conducting trials with ‘new drugs’ no longer need approval from the DCGI for the conduct of the trial and IEC approval would suffice. Also, customs authorities at the port of entry/exit shall permit the export of biological samples without prior approvals from any government agency, provided the concerned firm submits an undertaking confirming adherence to rules for safe transfer, and disposal of biological samples.

The rising number of clinical trials post new regulations in 2014

The number of drug approvals has been observed to increase in 2015 after three-tier reviews based on the cases. Clearly, the rising number of clinical trials being approved in India since 2014 is evident from the above figure. Moreover, from 2016 onward, slow revival has been reported, with Phase IV trials seeing an increase by 10 to 14 percent from 2015. 

As we can see from the latest available data, the Indian environment is again becoming conducive to clinical trials owing to the refined regulations and reduced approval times as well as the overall improved and more structured regulatory framework. Conducting trials in an emerging market like India, where expenses are lesser and the patient pool is bigger, can significantly benefit sponsor pharmaceutical companies, while also helping the local healthcare system and the economy of the developing country. With not only the huge population but also ever improving socioeconomic status; India is one of the rapidly growing destinations for both the conduct of the clinical studies as well as the marketing of new drugs. With GCP and investigators at par with the global standards, supported by a large patient base, Indian clinical trials could be the solution that the industry is seeking for high-quality data, expeditious study enrolments, and low cost.

Veeda Clinical Research is a rapidly growing CRO in India, where we strive to keep up with the current regulatory updates and provide our customers with comprehensive services, such as Phase II-III clinical trials, feasibility studies, end-to-end regulatory submissions, comprehensive project management, data management and statistics solutions among others.

Late phase study is conducted to evaluate drugs long term effectiveness and impact on patient quality of life over a longer period.

These studies provide ongoing safety information through the long-term evaluation of patients in a real-world setting. Regulatory agencies may require additional data about the side effects of new compounds. 

Late phase services include regulatory affairs, site qualification, site management, monitoring, data management, trial logistics, Pharmacovigilance, biostatistics, medical writing, and project management.

Late phase Contains phase II, Phase III and Phase IV.

Where in, In Phase II trials once a dose or range of doses is determined in Phase I, the next goal is to evaluate whether the drug has any biological activity or effect.

Phase III trials compare new treatments with the best currently available treatment with objectives of which treatment works better for a particular type of cancer, more about the side effects, how the treatment affects people’s quality of life.

In Phase IV trial, done after a drug has been shown to work and has been licensed and more concern about the effects and safety of the drug, what the long term risks and benefits are, how well the drug works when it’s used more widely.

Full-service CRO is Contract Research Organization is an organization contracted by other companies to manage, provide and lead clinical trials and other research support services for medical devices industries, biotechnology, Pharmaceuticals and also works with universities, government institutions, and foundations.

With this changing economy and innovation in the pharma industry, Pharma companies mostly outsource their critical functions including research and manufacturing. So, The Pharma companies mostly looking for full service CRO for their clinical trials and to develop new medication as well.

The company’s main focus is to reduce the time it takes to conduct a trial versus doing in house trials that render significant cost savings. Outsourcing these things will reduce costs like the company doesn’t have to build extra infrastructure, office space or use manpower to run these trials themselves. As there are many numerous and unidentified diseases acquiring big populations. This population desperately needs better medical care with the discovery of uncovering new medicines.

It’s better to start with some expertise rather than doing something about which you don’t know, the reason being this company contracts with full service CROs to acquire specific expertise without hiring permanent staff.

There are types of comprehensive services provided by CRO’s which includes Project management, Data entry and validation, Clinical trial data management, medicines, and design coding, quality and metric reporting, statistical analysis plans and reports, Validation programming, safety and efficacy summaries, final study report and database design and built, etc. to the company with the full service CRO contracted.

A best CRO (Contract research organization) is a company that supports the biotechnology, pharmaceutical and medical devices firms in form of clinical research and clinical trials services outsourced on some contract basis. Which provides services as preclinical research, Pharmacovigilance, clinical trial management, clinical research and biopharmaceutical development.

Most of the pharma firm developing medicines and drugs in niche market outsourced the services provided by CRO to reduce cost.

The best CRO services are the ones which provided by any CRO to the contracted company in desired timeline and cost effective. Best CRO services aims to simplify entry into drug market and development as well. Because everything doing in house now inessential for large pharmaceutical companies. Contract research organization provides clinical study and clinical trial support and it ranges from international, large full service organization to niche, small speciality group. CRO testing services are required throughout the development phase of any drug substance. Outsourcing CRO services helps pharmaceutical and biopharmaceutical firms to alleviate risks by avoiding large investments. It also helps pharmaceutical companies to focus on their core competencies. Thus, the development of new drug molecules is expected to drive the demand for CRO services.

Some CROs manage almost all features of a clinical trial, from position of selection and patient enrolment through final regulatory approval from the Food and Drug Administration (FDA).

Although a trial promoter may transfer all trial functions to a third-party CRO, the promoter remains responsible for the honesty of the trial data and to ensure it is all factual and backed by good science.

Types of Services Provided by CROs

Contract research organizations offer comprehensive services, including:

• Project management
• Database design & build
• Data entry & validation
• Clinical trial data management
• Medicine and disease coding
• Quality and metric reporting
• Statistical analysis plans and reports
• Validation programming
• Safety and efficacy summaries
• Final study report

Biopharmaceutics is a major branch in pharmaceutical sciences that relates between the physicochemical properties of a drug in dosage form and the pharmacology, toxicology, or clinical response observed after its administration. The importance of the drug substance and the drug formulation on absorption is described as a sequence of events that precede the elicitation of a drug’s therapeutic effect.

Drug efficacy and safety are dependent on the dosing regimen. The optimal dosage and dosing intervals can be quite different for different drugs. Moreover, for a single drug, the optimal dosage can be different widely between patients.

It is not sufficient to know what the drug does to the body; it is also crucial to know what the body does to the drug. The knowledge of the pharmacodynamics and pharmacokineticproperties of the drug and its metabolites in humans and animals is crucial to understand its different effects among species and for adjusting drug dosing. The plasma concentration in Biopharmaceutics of the drug is the basic concept of pharmacokinetics. Based on the protein binding of the drug, the concentration of free drug available in the circulation influences greatly the dose calculations. The concentration of drug in the plasma is in equilibrium with some tissues in the body.

Biopharmaceutics has evolved into a broad-based discipline that encompasses fundamental principles from basic scientific and related disciplines, including chemistry, physiology, physics, statistics, engineering, mathematics, microbiology, enzymology, and cell biology. The biopharmaceutical scientist, therefore, must have a sufficient understanding of all of these scientific fields in order to be most effective in a drug development role. For the subsequent discussion, we will look broadly at the areas of physical pharmacy (pharmaceutics) and PK and their roles and interdependencies in the drug development process.