For any sector, research is key to continuous development. This is especially true in the pharmaceutical and biotechnology realms, which focus on healthcare research. 

The sector is now making progress toward increased specialization and improved operational efficiency in this research. In this context, contract research organizations (CROs) have become essential. 

What and why

CROs are organizations specializing in clinical research. Different CROs may have expertise across various stages of the research process, but overall, they deliver outsourced services to the pharmaceutical, biotechnology, and medical device industries. 

The scope of CRO service may cover the entire spectrum of clinical development, from pre-clinical studies to post-marketing surveillance. More commonly, however, different CROs may be engaged at different stages, rather than one completing the entire race from start to finish.

Key responsibilities of CROs include conducting Phase 0-IV trials, bioequivalence/bioavailability studies, pharmacovigilance surveillance, and managing regulatory submission processes for new drugs. They may also offer laboratory analyses, data management, biostatistics, and medical writing services.

Key operations 

CROs operate through a combination of scientific expertise, project management, regulatory expertise, and stakeholder management. All these typically involve the following stages:

Project Initiation and Planning

CROs are engaged by pharmaceutical or biotech firms (sponsors) to research on their behalf. CRO will then develop a project plan, outlining scope, timeline, protocol, and budget in consultation with the sponsor.  

Approvals: Any clinical research requires local regulatory and ethical approvals. CROs submit the requisite documents to secure that. 

Site selection and management: Clinical trials will need to be conducted at designated sites and led by a team of qualified investigators, in accordance with Good Clinical Practice (GCP) guidelines. CROs will ensure adherence to GCP and select appropriate sites and investigators for the trial. They usually have an extensive network of hospitals, clinics, and physicians.

Data collection: CROs develop recruitment strategies to enroll eligible participants, ensuring diversity across demographics and geographies. They are responsible for ensuring that protocol and proper ethical standards are followed.

Monitoring: Both on-site and remote monitoring are used to minimize risks. Quality checked at every stage of the clinical trial process, ensuring rigorous compliance with GCP and regulatory standards. There will, of course, be deviations, but the protocol delineates how to address that. 

Data analysis and reporting: Biostatisticians affiliated with CROs perform detailed analyses of trial data and generate interim and final reports. Findings are interpreted and disseminated to sponsors and regulatory bodies; significant results may be published in peer-reviewed journals.

Regulatory submission and post-marketing surveillance: CROs compile documentation for regulatory submissions and address inquiries from authorities. CROs may continue to oversee post-marketing surveillance to monitor product safety and efficacy.

Impact on healthcare research 

CROs possess extensive knowledge of international, regional, and national regulations. They ensure consistent compliance, mitigating the risk of delays or regulatory setbacks. CROs’ familiarity and lobbying with regulatory agencies also result in faster approval.

On the other hand, clinical trials are expensive. The cost could reach billions of dollars. CROs can optimize time and resources to eliminate redundancies and make trials more cost-effective. 

CROs can also conduct multi-center trials across diverse regions, facilitating access to varied patient populations across geographical areas and improving the validity of research findings.

How do the sponsors benefit from CROs

Outsourcing clinical research activities enables sponsors to focus on their core competencies, such as drug discovery, commercialization, and other strategic projects. 

They benefit from the strong networks CROs provide. CROs are often able to propose novel trial designs, adaptive protocols, and digital solutions that enhance the quality and relevance of research.

Regulations

Apart from local regulations, CROs must also comply with international standards. 

All clinical trials must meet the GCP standard, which is non-negotiable. GCP provides an ethical and scientific benchmark for the design, conduct, and reporting of clinical trials. It safeguards the rights and welfare of trial subjects and assures the integrity of data. 

ICH (International Conference on Harmonization) GCP guidelines harmonize regulatory expectations across major jurisdictions, including the United States, the European Union, and Japan. CROs are required to adhere to these standards in multinational research endeavors.

In the United States, CROs must comply with the FDA’s (Food and Drug Administration) Title 21 Code of Federal Regulations, which encompasses requirements for electronic records (21 CFR Part 11).

The European Medicines Agency (EMA) guidelines regulate the development and conduct of clinical trials within the European Union. CROs must adhere to EMA directives regarding patient safety, data integrity, and trial execution.

CROs are obliged to comply with data protection regulations, including the General Data Protection Regulation (GDPR) in the European Union and the Health Insurance Portability and Accountability Act (HIPAA) in the United States.

Local ethics committees or Institutional Review Boards (IRBs) must sanction clinical trials to ensure ethical integrity and protect research participants.

CROs in Bangladesh

Bangladesh’s clinical research sector is still in its early stages; indigenous CROs are still scarce. A few major international CROs have established a presence in the country. 

Local CRO services typically encompass ethics and regulatory approval, site selection, patient enrollment, trial monitoring, quality assurance, statistical analysis, and report writing, among other services. 

However, the industry faces challenges such as infrastructure limitations, regulatory complexities, and a lack of qualified experts in this field. 

Gonoshasthaya Pharmaceuticals and Globe Pharmaceuticals are two of the CRO industry leaders in Bangladesh. These are not specialized CROs, though; instead, CRO service is offered as an extension of their overall operations. 

There are local offices and partnerships with global CROs, such as IQVIA, Syneos Health, or PPD, to facilitate multinational trials. Most CROs in Bangladesh offer services ranging from Phase I to IV clinical trial management to biostatistics, pharmacovigilance, site monitoring, and ethics committee coordination. 

There are collaborations among universities, hospitals, and CROs, with academic institutions such as the University of Dhaka and the Bangladesh Medical Research Council (BMRC).

Nevertheless, lower labor costs, affordable infrastructure, and lower overheads make research projects in Bangladesh more financially viable than in Western nations.

The country’s large, diverse, and treatment-naive population is advantageous for recruiting clinical trial participants, particularly for investigations into infectious diseases and chronic conditions prevalent in South Asia.

Additionally, the country is experiencing a surge in the pharmaceutical sector and is continually updating its regulatory frameworks. Academia is also stepping up with qualified researchers and clinicians.

Challenges 

In Bangladesh, regulatory procedures are often slow, vague, and inconsistently applied, resulting in delays in approval and oversight. Also, inadequate electronic data capture systems, cold chain logistics, and laboratory networks fail to meet accepted standards.

There is also a shortage of experienced clinical research personnel, particularly those proficient in multinational protocols and innovative trial designs.

Yet Bangladesh needs to look into the issues and work to resolve them. CROs offer easy scalability, efficient project management, and regulatory expertise. This leads to faster market reach and economic boom as well.

Dr. Imtiaz Ahmed graduated from Dhaka Medical College and currently resides in Canada. He has over seven years of experience in healthcare compliance. Currently, he works with patient support programs and supports auditors and external regulators to ensure compliance with relevant laws and procedures. He was part of the internal team that investigated opioid crisis-related issues at the company and coordinated with external stakeholders.