Quality and compliance
A sponsor is accountable for the quality of its study, even when the work is contracted out. This page sets out what we are licensed to do, the standards we follow and how our quality system works, so that you can assess us before you write to us.
“Quality is not a department here. Every procedure we follow is written down, every person is trained on it before they use it, and every deviation is recorded and followed to closure.”
Dr Anila Sikandar, Quality Assurance Manager
Licence and registrations
Contract Research Organisation Licence
- Licence No.
- CRO-0036
- Issued by
- Drug Regulatory Authority of Pakistan
- Issued
- 27 August 2026
- Valid
- Three years
- Under
- Bio-Study Rules 2017
The licence was granted after DRAP inspected our premises, procedures and personnel. The company is incorporated with the Securities and Exchange Commission of Pakistan as Innovex Health CRO Private Limited.
- Registered office
- Plot 117, Street 8, Industrial Area, I-10/3, Islamabad, Pakistan
Standards we work to
We name the standard that governs each type of work, and our procedures are written against it.
| Standard | Applies to |
|---|---|
| ICH E6 Good Clinical Practice | All clinical studies of medicines |
| ISO 14155 | Clinical investigations of medical devices |
| ISO 20916:2019 | Clinical performance studies of in vitro diagnostic devices |
| Bio-Study Rules 2017 (Pakistan) | Licensing and conduct of clinical studies in Pakistan |
| DRAP Medical Devices Rules 2017 | Device and IVD classification and registration |
| ICH E3 | Structure and content of clinical study reports |
| CLSI EP05, EP09, EP12 | Analytical and performance evaluation methods for IVDs |
| Declaration of Helsinki | Ethical conduct of research involving people |
Quality system
Our quality management system is documented in a controlled set of standard operating procedures. Each procedure has an author, a reviewer and an approver, an effective date and a scheduled review date.
Areas our procedures cover
- Company governance and the CRO master file
- Clinical trial management and oversight
- Clinical data management
- Biological sample management
- Clinical performance studies of in vitro diagnostics
- Safety and pharmacovigilance
- Regulatory affairs
- Quality management, audit and CAPA
- Document control and the trial master file
- Training and personnel
- Facilities, IT and computerised system validation
Training
No one works on a study until they have been trained on Good Clinical Practice, the relevant procedures and the study protocol. Training is recorded and competence is assessed.
Audit
Our quality assurance function audits internal processes, study conduct and critical vendors to a planned schedule. It reports to senior management independently of the teams it audits.
Corrective and preventive action
Every deviation, audit finding and complaint is logged, investigated for root cause and tracked until the corrective action is verified as effective.
Vendors
Laboratories and other critical vendors are assessed before they are engaged and audited while they work for us.
Data integrity and systems
We manage study data so that it is attributable, legible, contemporaneous, original and accurate.
- Electronic data capture. Study data is captured in OpenClinica. Each user has an individual account with access limited to their role.
- Audit trail. Every entry and every change is recorded with the user, date, time and reason.
- Validation. Each study database is tested and documented before it goes live.
- Backup. Electronic data is backed up on a defined schedule.
- Archive. Paper records are kept in a dedicated, access-controlled archive room for the retention period the regulations and your contract require.
- Confidentiality. Participant data is coded. Staff and vendors are bound by confidentiality agreements.
Our premises in Islamabad
Purpose-built ground-floor premises with layered, role-based access control. Study records are kept in a dedicated archive with access and environmental controls, for the retention period the regulations and each sponsor require, and are destroyed securely and on record at the end of it.
Independence and conflict of interest
Study results must not be influenced by anyone’s financial or personal interests. Our conflict of interest policy applies to directors, staff, consultants and vendors.
- Declaration. Interests are declared on appointment, annually and whenever they change.
- Recusal. Anyone with an interest in a decision takes no part in it.
- Arm’s-length terms. Vendors are selected and paid on documented, market-based terms.
- Independent audit. Quality assurance audits are carried out by people with no interest in the work audited.
- Disclosure. Relevant interests are disclosed to sponsors before a contract is signed.
Qualifying us as a vendor?
We will send our qualification pack and host an audit, on site or remotely.