Overview — Pharmedas Clinical Research

Our clinical operation group can manage your clinical development programmes effectively through comprehensive site management, optimal study start-up, patient recruitment and robust monitoring. We are aware of the clients’ need of meeting the project delivery timelines and budget. This will remain our watch words from the time the project contract is signed to its conclusion.

The need for audit is well-established in GCP and many regulations. The importance of audit, especially of partners, cannot be over-emphasized.
It is very challenging, for example, for a QPPV that is based in a Belgian office to keep the required oversight of the company’s marketing partner in Bahrain effectively. It is challenging to ensure that the Bahraini partner has the pharmacovigilance system in place and is maintaining the required compliance with local regulations and the inter-company pharmacovigilance agreement.
This is where we come in. We can audit your partner and provide your organization with a full report and recommendations. We can work together to effect some of the recommended CAPAs and even take over some of the roles of your partners, if required, to help organization maintain full compliance.

We undertake all works within the pharmacovigilance sphere. We can set up and advise on pharmacovigilance systems, manage individual and composite cases and reports. We can handle you documents such as PSURs, PABERS, Risk MAPs, RMP and CTD summaries such 2.7.3, 2.7.4 and 2.5

We have a good knowledge of local requirements in regions where we operate. This gives us edge over our “global” competitors. We very efficient in securing clinical trials and marketing authorisation approvals. We can assure our clients with good and effective 3-way communication and liaison with local regulatory authorities that will enable prompt decision-makings.
Our regulatory team will support the development strategy, clinical trial and marketing authorisation submissions, and provide post-authorisation support.

The project management team assigned to your project will be the single point of contact with Pharmedas. We will ensure accountability, transparency and successful delivery.

Pharmedas physicians and other clinical operation personnel are always in hand to provide support in the planning, conduct, and evaluation of clinical trials. We will provide the insight that will help in designing a robust study by critically appraising all sections of the protocol. Our project team members can combine to deliver high quality medical Monitoring, training and support, protocol reviews, investigator engagement, data reviews, safety analyses and study reports. Our medical staff are knowledgeable and well-trained and have the expertise to support Phase II-IV clinical studies up to the point of regulatory submission.
Our approach to monitoring of clinical studies is proactive, risk-based and adaptive. At Pharmedas, we put patients first. Our monitors and medical leads are always on the lookout for pointers of issues that may impact on the study. These are analysed with the sponsor so that appropriate actions are taken.

We have a comprehensive database of sites and various specialists that will facilitate rapid identification of potential investigators. Our clinical staff will also train the site staff on protocol related and technical matters. Furthermore, we can monitor for compliance with the study plan, protocol and IRB review, and control of investigational products, as well as report safety data, inform sites about performance and contractual issues, and serve as a point of contact between site, sponsor, regulatory agencies and ethic committees.

Contract Clinical Research