PSC CLINICAL

CLINICAL TRIALS SERVICES

SERVICES SUITED TO YOUR REQUIREMENTS

PSC Clinical offers a full range of study management and quality control services that study sponsors may select to meet their needs – from a complete outsourcing solution to specific services that will complement the work of in-house staff and provide independent verification.

The people of PSC Clinical share a commitment to quality, integrity, and service that is unmatched in the industry. Our high performance standards can help clients avoid regulatory trouble and correct issues identified by regulatory review.

We consider it our mission to preserve medicine and those who test it by ensuring the highest quality of study services.

	Clinical Trial Management Services PSC Clinical will meet the clinical research needs of large and small companies with an unsurpassed level of quality. Our experts have years of experience which will ease the pressure on you while enhancing your staff's own expertise. With offices all around the world, we can respond anywhere at anytime in a timely manner. Let us earn your trust.
	Protocol Development and Review PSC Clinical’s interactive approach to protocol development ensures that communication is established early on in the trial process, which is a key to success. PSC can help you design more efficient protocols, resolve potential issues early in the process, and avoid extraneous procedures. This results in cost savings, more effective subject recruitment, and enhanced subject retention.
	Clinical Monitoring Services PSC regional monitors provide monitoring of protocols to the sponsor’s specifications. The sites that we monitor tell us that they enjoy working with our monitors because we are thorough yet respectful of their knowledge and time. Our monitors are always accessible to answer questions and provide assistance with protocols. We also provide project management for a complete outsourced monitoring service for sponsors. Our International monitors assure that regulatory requirements and sponsor requirements are met across the globe – no matter where the trial is being conducted.
	Medical Monitoring Our medical monitors provide expert assistance in all phases of a trial from the planning stages and recruiting to data collection and regulatory submissions. In addition to monitoring throughout the U.S., PSC Clinical specializes in medical monitoring for studies conducted in Latin America and can provide services wherever needed around the globe.
	Clinical Audit Services PSC Clinical performs a variety of audits, including: Clinical Research Site Audits for compliance with Good Clinical Practices (FDA and ICH), Good Laboratory Practices, EMEA regulations, National Cancer Institute (NCI) protocols and requirements, and other regulatory requirements. Vendor Audits for sponsors including pre-clinical, Phase I – III sites, data management companies, safety laboratories, bioanalytical laboratories, and internal sponsor audits. IRB Audits to assure that patient safety is being met, and that your IRB meets Federal and International guidelines.
	Data Management PSC Clinical offers several data management options to suit the needs of large and small trials. Our solutions are compliant with the FDA’s Guidance on Computerized Systems Used In Clinical Trials.
	Computerized System Validation PSC Clinical has a long history of computerized system validation to meet the requirements defined in the FDA’s Guidance for Industry: Computerized Systems Used in Clinical Trials and in 21 CFR Part 11. Applications that we have validated include those that generate electronic CRFs, those that manage laboratory data (LIMS), clinical trials management systems, data management systems, bioinformatics systems, Excel spreadsheets, Access databases, and others.
	21 CFR Part 11 Compliance Services Compliance to 21 CFR Part 11, Electronic Records and Electronic Signatures often requires a combination of software, hardware, and procedural controls. PSC Clinical has the expertise to analyze the compliance needs and develop the processes to comply with the requirements of this regulation.
	SOP Development PSC can assist you in developing individual Standard Operating Procedures (SOPs), or in developing a complete program of Policies, Processes, Procedures, and Forms to aid your clinical research staff in adhering to the requirements of protocols, sponsor requirements, and Federal requirements.
	Good Clinical Practices Training We offer a variety of interesting, pertinent topics for annual GCP training, delivered in an interactive session that will engage and educate your staff. Contact us for potential topics.
	Quality Assurance PSC has deep expertise in implementing and maintaining Quality Assurance Programs in the drug, medical device, biologics, biotechnology, and laboratory industries, as well as in academic medical centers and clinics. We can assist you in developing the right QA program for your environment and size.
	Process Development and Process Improvement Process improvements come about through a program of auditing, analysis of observations, implementation of improvements, and assessment of outcomes. PSC consultants will show you how to make process improvements a reality.
	Best Practices Development and Implementation Best Practices vary among industries and clinical research environments. Because PSC auditors and consultants have experience in a wide variety of clinical research settings, we can help you identify and implement the best practices for your own environment.
	Report and Submission Development Summary reports of pre-clinical and clinical studies are used to convey the results of these studies in a way that is understandable. PSC CLinical has the expertise to write summary reports and to organized study results into an FDA submission document. Our submission documents are clearly understood and regularly accepted by FDA reviewers.
	Data Management and Trial Management Hosting Acquiring, configuring, validating and maintaining a clinical trial, data management or trial management system can be a big investment of time and money. When PSC manages your electronic trials systems, you can be assured of a quick start-up, little investment in additional hardware, a fully validated 21 CFR Part 11 Compliance System, and 24/7 support. We can host the system you have chosen or assist you in selecting the system that best fits your needs.