The Clinical process is simplified with our operational expertise for collaborative planning, implementation and management.
Clinical operation is undoubtedly one of the most critical aspects of clinical research. It takes a lot of effort to plan and execute clinical research while mitigating risks meticulously. Moreover, with increased regulations and guidelines, it has become progressively critical to put time and effort into engaging a clinical operations team that can swiftly handle the compliance as well as fulfill all the requirements.
Successful and smooth execution of a clinical trial requires a lot of effort. There can be so many impending challenges like slow enrolment, site problems, delayed implementation of amendments etc. In fact, site or CRO problems can sometimes derail a clinical program. Global Pharma Tek in partnership with Dedicated Site Solutions provides SWAT/Rescue (study within a trial) monitoring services across the United States in all time zones. If required, monitoring resources can be trained as per the client’s protocol and on the first site visit within seven days.
Clinical trials have expanded to multiple dimensions and require apt management for its successful accomplishment. But this is not an easy task owing to different complexities and criticalities of the clinical research. Global Pharma Tek’s team of highly experienced and sharpened project managers are masters in managing complex reviews across various therapeutic areas around the globe. Our team is well versed and eager to achieve operational perfection by following best industry practices to deliver on-time and high-quality outcomes.
Our project administration group caters to all the needs of our clients in the key market areas of Asia, Europe and North America.
Our project administration group caters to our clients’ needs in the key market areas of Asia, Europe, and North America. The teams have a sharpened aptitude and are constantly trained to deliver better outcomes to our clients. They are committed to keeping the project on track while maintaining its quality. Global Pharma Tek gives 24×7 support to all the clients for eligibility review and exact randomization of a subject.
Clinical documentation is an important part of clinical research. More important, clinical documentation must be compliant to the stringent regulatory standards and regulation. Thus, it is necessary to have a documentation system that guarantees quality documentation according to the regulations and is compliant with ICH-GCP and other standard operating procedures. Global Pharma Tek offers a well-planned and robust clinical trial management framework that is compliant with 21 CFR Part 11 and can strengthen archive tracking at the global level.