Simplifying your clinical process from study start-up to submission with our clinical strategy.
As drug pipelines limit and the quantity of drugs that make it to the market diminishes, it has turned out to be progressively critical to put time and efforts in the clinical operations handlers. The range of work that falls under clinical operations starts with the choice of the correct accomplice who can arrange the venture similarly as his own.
At Global PharmaTek, we offer end-to-end services to lead clinical trials for a wide range of drugs.
Clinical Trial Feasibility
Feasibility studies are a fundamental segment of study set up, which includes breaking down key regulatory contemplation and viable ramifications of leading clinical research in a specific geology.
Worldwide PharmaTek’s broad clinical system and experience help you in methodology arranging and recognizing the most productive and quick courses of achievement in leading clinical trials. Our involvement in leading clinical review feasibility spreads over the globe.
You can be certain of leading your review with our ongoing databases and devoted assets for recognizable proof of new investigators and sites. We additionally give the clinical trial important and viably data to make the study more effective.
Clinical Project Management
Talented project administration is the way to the accomplishment of any clinical trial. With an expansion in the many-sided quality of clinical trials, the significance of successful project administration has gone to the fore. To go to different complexities of the trial, you require a group that is not quite recently experienced but rather is likewise creative, adaptable and agile.
At Global PharmaTek, we have sharpened our project administration mastery by directing complex reviews in diverse therapeutic areas and boards across the globe. Furthermore, the area of the project administration group has been planned remembering the necessities of our customers in the key markets of North America, Europe, and Asia.
Our project administration group holds fast to the most noteworthy guidelines of operational perfection and ‘built up industry best practices’ to guarantee high caliber and on-time deliverable’s. With SOP’s intended to guarantee smooth correspondence, joint effort, and project proprietorship, you can be rest guaranteed that your venture is in fit hands.
Over the span of your trial, the clinical monitoring group has the support of our committed medical monitoring group of experienced experts crosswise over therapeutic areas and periods of the review. The team guarantees definite clinical review convention audit in the relationship with the investigator brochure to distinguish foreseen challenges amid execution of your review.
Their expectant aptitudes are sharpened by involvement and constant training programs that help them deliver better outcomes. Normal training’s to the Project administration and clinical monitoring groups create positive groups on the field. Our medical monitoring group helps the project remain on track and attain quality. We give clinical data management that guarantees research is done accurately and quickly to reduce the time to market.
Global PharmaTek group likewise gives 24×7 supports to all the parties for eligibility review and for any inquiry to guarantee exact randomization of a subject.
Documentation constitutes an indispensable piece of Clinical Research Industry bound by stringent standards and regulation.With methodical recording and right documentation forms, an established documentation framework is one of the dire needs of the working models of clinical operations. Addressing this need, the Clinical Documentation system was established at Global PharmaTek. The documentation group is exclusively committed to guaranteeing quality documentation as far as local regulations, ICH-GCP compliance, and standard operating procedures. Global PharmaTek offers a structured and robust 21 CFR Part 11 compliant clinical trial management framework to bolster archive tracking at the global level.
In a domain of intense regulatory scrutiny and heightened complexity of clinical trials, overseeing clinical information has turned out to be a standout amongst the most difficult tasks confronting all partners of the bio-pharmaceutical domain.
Low-quality information will be a hindrance to the regulatory acceptance of a molecule and additionally can defer market release. Hence, bio-pharmaceutical organizations perceived to deliver excellent information, in a cost effective way.