Clinical process simplified with our operational expertise for collaborative planning, implementation andmanagement.
Clinical operation is undoubtedly one of the most critical aspect of clinical research. It takes a lot of efforts to finely plan and execute a clinical research while mitigating risks.Moreover, with increased regulations and guidelines, it has become progressively critical to put time and efforts in engaging a clinical operations team that can swiftly handle the compliance as well as fulfil all the requirements.
At Global Pharma Tek, we offer end-to-end and customized clinical operations services to aggressively lead clinical trials for a wide range of drugs around the globe.
Problem Solving Monitoring Solutions
Successful and smooth execution of a clinical trial requires lot of efforts. There can be so many problems like slow enrollment, 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 provide SWAT/Rescue (study within a trial)monitoring services across the United States in all time zones. Also, if required, monitoring resources can be trained as per client’s protocol and on the first site visit within 7 days.
High-points of our experienced and dedicated rescue monitoring team
- Work in short timelines
- Attention to critical endpoints
- Proven site relationships with KOLs in multiple indications
- Historical relationships with major healthcare facilities and group practices across the United States
- Work singularly or in groups for rescue monitoring
Clinical Trial Feasibility
Clinical Feasibility Services to Asses & Mitigate Research Delays
Being a fundamental segment of study set up, feasibility studies includes thorough review of regulatory contemplation and execution of viable ramifications for the success of a clinical research in a specific geology.
Global Pharma Tek’s broad expertise, global presence and systematic clinical system helps in assessing the methodology and recognizing the most productive and quick actions to achieve clinical research success. Our ever-increasing database can give you recognizable proof of new investigators and sites. We alsoprovide important and viable data to make the clinical study more effective.
Clinical Project Management
Adaptive, Creative & Agile Clinical Project Administration
Clinical trials have expanded into many sides and requiresapt management forits 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 therapeuticareas 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.
Medical Monitoring to Stay on Track
Our medical monitoring group comprises of experts of various therapeutic areas who can foresee challenges in your research and monitor it for improved execution. The team has a sharpened aptitude and are constantly trained to deliver better outcomes to our clients. They are committed to keep the project on track while maintaining its quality. Global PharmaTek gives 24×7 support to all the clients for eligibility review and exact randomization of a subject.
Compliant Clinical Documentation System
Clinical documentation is an important part of clinical research. More important, clinical documentation must be compliant to the stringent regulatory standards and regulation. Thus, there is a dire need 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.