As a Contract Research Organization, OrciTrials is dedicated to advancing medical research and improving healthcare outcomes through Pre-Clinical and Clinical Trials. In addition to our core services, we also offer Quality Assurance and External Audit services to ensure that our clients’ trials are conducted in compliance with global regulations and best practices.

OrciTrials’ Commitment to Advancing Medical Research and Improving Healthcare Outcomes

Our team of experienced auditors and quality assurance professionals provide comprehensive support to clients in all stages of their clinical trials, from protocol development to final reporting. We have extensive knowledge and experience in global and local regulations, guidelines, and our audits are tailored to meet the specific needs of each client.

Regulatory compliance

 We ensure that all aspects of the trial, from informed consent to report writing and publication, are conducted in compliance with global regulations.

Good Clinical Practice (GCP) compliance

 We assess whether the trial adheres to GCP guidelines, ensuring the integrity of the data and the safety of trial participants.

Clinical Quality Control Services

OrciTrials also provides Clinical Quality Control (QC) services to ensure that clinical trials are conducted to the highest standards of quality. Our experienced team of professionals provides ongoing monitoring of the trial to identify and resolve issues that may impact the accuracy and reliability of the trial results.

Ongoing Monitoring to Regulatory Compliance

Our Clinical Quality Control services include regular site visits, source data verification, and ongoing review of clinical data to ensure that the trial is progressing according to the protocol and meeting all regulatory requirements. Our goal is to help our clients achieve their trial objectives by ensuring that their study is conducted to the highest standards of quality and compliance.

Process of External Audits

Our external audit process is designed to provide a comprehensive review of the clinical trials, covering all critical aspects of the clinical study. Our team of auditors follows a rigorous process that includes a detailed review of the trial documents, on-site visits, and interviews with study personnel to ensure that all processes are compliant with global regulations and best practices.

List of documents typically audited during a clinical trial. This list includes:

1. Trial Master File (TMF) – a collection of essential documents related to the clinical trial.
2. Informed Consent Form (ICF) – a document that outlines the purpose, risks, and benefits of participating in a clinical trial.
3. Case Report Form (CRF) – a document used to collect data from each participant in the study.
4. Investigator Brochure (IB) – a document that provides essential information about the drug or device being studied.
5. Protocol – a document that outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
6. Statistical Analysis Plan (SAP) – a document that outlines the statistical methods to be used in analyzing the data collected during the trial.
7. Clinical Study Report (CSR) – a document that summarizes the results and conclusions of the trial.
8. Data Management Plan (DMP) – a document that outlines the procedures for collecting, managing, and analyzing data during the trial.
9. Adverse Event (AE) and Serious Adverse Event (SAE) reports – documents that report any adverse events or serious adverse events experienced by participants during the trial.
10. Investigator Brochure – a document that outlines the procedures for handling and dispensing the investigational drug or device.
11. Monitoring Plan – a document that outlines the procedures for monitoring the conduct of the trial.
12. Quality Management Plan (QMP) – a document that outlines the procedures for ensuring the quality of the trial conduct and the data.

Note that this is not an exhaustive list, and the documents required for an audit may vary depending on the specific trial and regulatory requirements.

Benefits of External Audits

External audits provide several benefits for clients, including increased confidence in trial results, improved data quality, and reduced risk of non-compliance. Additionally, external audits can help identify potential issues early on in the trial, allowing for corrective action to be taken before the trial is completed.

Collaboration with Sponsors

We work closely with our clients and their sponsors throughout the external audit process, ensuring that all audit findings are communicated clearly and that corrective action plans are developed in collaboration with all parties. Our collaborative approach ensures that all stakeholders are aligned on the path forward and that the trial is conducted to the highest standards of quality and compliance.

GCP Auditing Experience

At OrciTrials, our team of auditors has extensive experience conducting external GCP audits of clinical trials. We have audited trials in a wide range of therapeutic areas, including oncology, cardiology, infectious diseases, and more. Our team has a deep understanding of global regulations and best practices, ensuring that our audits are comprehensive and rigorous.

Clinical Quality Assurance Reporting

At the end of each external audit, we provide our clients with a detailed report that includes all audit findings and recommendations for corrective action. Our reports are designed to be clear and easy to understand, providing clients with a comprehensive overview of the trial’s compliance status and areas for improvement.

The Importance of External Audits in Clinical Trials

External audits are a critical component of ensuring the quality and compliance of clinical trials. At OrciTrials, we are dedicated to providing our clients with the highest quality external audit services, leveraging our experience, expertise, and collaborative approach to ensure the success of each trial.

Partnering with OrciTrials for Quality Assurance and External Audit Services

At OrciTrials, we understand the importance of quality assurance and external audits in ensuring the success of clinical trials. By partnering with us for these services, our clients can rest assured that their study will be conducted to the highest standards of quality and compliance.

Tailored Services for Global Clinical Trials

Our Quality Assurance and External Audit services are available anywhere in the world where our clients’ clinical trials are running. Our team works closely with clients to tailor our services to their specific needs, ensuring that they receive the support and guidance they need to achieve their study objectives.

Committed to Delivering High-Quality Clinical Trials

OrciTrials is committed to delivering high-quality Pre-Clinical and Clinical Trials, and our Quality Assurance and External Audit services are an integral part of this commitment. We are dedicated to ensuring that our clients’ studies are conducted to the highest standards of quality and compliance, and we look forward to working with our clients to achieve their study objectives.

Clinical trials are a crucial component of medical research because they enable researchers to evaluate novel therapies and drugs before they are made widely available. Clinical trials are important in the advancement of medical research, Pakistan has become an emerging player in this field. With the increasing focus on healthcare and medical research, Pakistan has become an attractive destination for conducting clinical trials. 

ClinicalTrials.gov Report: Pakistan Witnessing Steady Growth in Clinical Trials 

The number of clinical trials conducted in Pakistan has steadily increased over the last decade, according to a report by the ClinicalTrials.gov database. Pakistan was designated as a site for 141 clinical trials in 2011, with the number increasing to 214 trials by 2020. The majority of these studies were in oncology, infectious diseases, and cardiovascular disease. 

Pharma Industry on the Rise 

Furthermore, the pharmaceutical industry in Pakistan is expanding, with more local and international pharmaceutical companies investing in the country. This has resulted in increased collaboration between industry and research institutions, which has resulted in the development of new drugs and medical devices. 

Diverse Population, Generalized Results 

The clinical trial landscape in Pakistan has significantly improved in recent years, with the country now offering a variety of opportunities for both local and foreign researchers. The large population of Pakistan provides a large pool of participants, making it easier to recruit patients for clinical trials. In terms of local and foreign researcher participation, according to a 2019 study published in BMC Medical Ethics, 53.6% of the principal investigators of clinical trials conducted in Pakistan were local researchers, while the remaining 46.4% were foreign researchers. This suggests that local researchers make a significant contribution to clinical trials in Pakistan. Furthermore, because of the country’s diverse population, researchers can conduct trials on various ethnic groups, increasing the generalization of results. 

Enhancing Research Infrastructure: Pakistan’s Progress in Boosting Clinical Trials 

Pakistan has made significant progress in improving its research infrastructure in recent years, resulting in an increase in the number of clinical trials conducted. Clinical trials are being conducted by an increasing number of research institutions, including private organizations, universities, and hospitals. This has resulted in more collaboration between researchers and the pharmaceutical industry, which has resulted in the development of new drugs and medical devices. 

Committed to Ethical Clinical Trials 

In addition to the regulatory framework established by the DRAP, Pakistan has established an independent ethics committee to oversee clinical trial conduct. The National Bioethics Committee (NBC) was formed in 2006 to ensure that clinical trials are conducted in an ethical and international manner. The Pakistani government has also taken steps to facilitate clinical trials in the country. The Drug Regulatory Authority of Pakistan (DRAP) introduced new regulations in 2017 to ensure that clinical trials adhere to international standards. These regulations have resulted in an increase in the number of clinical trials being conducted in Pakistan, as they provide a clear framework for conducting trials and protect the rights of patients participating in these trials.  

Breaking Misconceptions: Addressing Public Concerns about Clinical Trials Safety in Pakistan 

Despite the progress made, there are still issues to be addressed. One of the major challenges is the general public’s lack of knowledge about clinical trials. Many people are hesitant to take part in clinical trials because they have misconceptions about the process and are concerned about the safety of the treatment being tested. As a result, researchers are having difficulty recruiting participants for their trials. 

Breaking the Barrier: Lack of Public Knowledge a Major Hurdle in Conducting Clinical Trials in Pakistan 

However, challenges remain in the field of clinical trials in Pakistan. The general public’s lack of knowledge about clinical trials has been identified as a significant barrier to recruitment. According to a study published in the journal BMC Public Health in 2020, many people in Pakistan were unaware of clinical trials and had misconceptions about the process. 

Pakistan’s Clinical Trial Progress: Opportunities and Challenges Ahead 

Finally, Pakistan has made significant progress in the field of clinical trials, providing a variety of opportunities for both domestic and international researchers. Pakistan is well-positioned to become a major player in medical research with the government’s support and the country’s improving research infrastructure. However, much work remains to be done to address the field’s challenges, including raising public awareness and investing in research infrastructure. 

Strengthening Research Capabilities 

More investment in research infrastructure is also required. Despite an increase in the number of research institutions, there is still a lack of adequate resources and trained personnel to conduct high-quality research. This includes the need for improved laboratory facilities, access to cutting-edge technologies and equipment, and research personnel training. 

A Promising Future 

Overall, the clinical trial landscape in Pakistan is promising, with the country providing a variety of opportunities for both local and foreign researchers. However, much work remains to be done to address the field’s challenges and ensure that clinical trials are conducted ethically and in accordance with international standards.