Our Services

Clinical Trials

We provides comprehensive range of Clinical trial services in Pakistan based on Compliance, Optimism, Regulation & Ethics (CORE)

CORE Values

We provides comprehensive range of Clinical trial services in Pakistan based on Compliance, Optimism, Regulation & Ethics (CORE)

Project Management

A successful clinical trial is built on effective and well-structured project management, which can prevent delays and increase costs. We will make sure that all pertinent data to support your study goals are managed with the utmost integrity adept with excellent leadership, negotiation, and communication skills. Throughout the project, our committed Project Manager will guarantee skilful management of time, resources, and budget.

Clinical Site Management

We hire highly qualified clinical research associates approved by Drug Regulatory Authority of Pakistan (DRAP) – Ministry of National Health Services, Regulations & Coordination (NHSRC). Our Clinical Research Associates manage investigator sites with the utmost efficiency, with a focus on maintaining data quality, subject safety, and quick problem-solving throughout the trial.

Vendor selection

We locate and facilitate effective third party vendor partnerships for different services. We have the right people with the necessary functional abilities and skills to effectively manage the vendor relationships. We thoroughly examine the vendor’s procedure and assess the vendors according to predetermined standards. We guarantee the chosen vendor’s compliance, conduct, budget, and ultimate success.

Clinical Data Management

For any scientific field, sound data management principles are essential. In order to obtain high-quality data that is accurate and complete, clinical research adheres to strict regulatory standards for data collection and management. We combine expertise with technology to guarantee actionable results, the highest level of data quality, and data integrity.

Medical Writing and Medical Monitoring

Our team of experienced medical writers possesses comprehensive knowledge and experience to cover the different demands of medical writing in clinical research. To ensure patient safety, our medical monitoring services include medical supervision of your trials by knowledgeable clinicians.

FAQ

General Questions

How are clinical Trials Regulated in Pakistan?

Drug Regulatory Authority of Pakistan (DRAP) is mandated to regulate the Clinical Trials and to implement internationally recognized standards as adopted by World Health Organization (WHO) and International Conference on Harmonization (ICH). The authority with approval of Federal Government, has notified the Bio-Study Rules 2017 for regulation of the clinical trials activities in the country.

What is Clinical Studies Committee (CSC)?

The CSC is responsible to assess that rights, safety and well-being of trial participants are protected before the start of clinical trial. This committee reviews the protocols and monitor the compliance to Good Clinical Practices (GCP) and cause inspection of Clinical Trial Site and CROs.

Who upholds the Ethical Approval of Clinical Trials?

National Bio-Ethics Committee is a notified body on bio-ethics working under the Ministry of National Health Services, Regulation and Coordination.