ARS Clinical Trials

Research Dynamics is a Clinical Research Organization (CRO) that provides high quality, flexible clinical trial services, GCP training, and consulting to the pharmaceutical, biotech, device industries as well as to investigators and academic medical centers. We use innovative technologies, experienced research professionals, and a commitment to clients through product development to approval.

As a full service CRO, we provide dedication, flexibility, value, and a unique depth of experience and expertise.
Complex trials or first trials in an emerging company require this depth of expertise and insight to ensure successful trial completion. Our strength is in our expericenced staff especially in clinical trial rescue studies where we can start work within 1-2 weeks. Our specialty is complex or difficult studies where our focused attention is needed.

As a focused CRO we concentrate on providing our clinical trial core competencies from site identification through trial conduct to final clean data collection. These activities include site monitoring, site management, project management, GCP auditing, regulatory document management and remote EDC monitoring.

As a full service CRO, we provide “best-in-class” experts for regulatory services, data management, statistics, pharmacovigilance, medical monitoring, etc. Our Clinical QA audit staff can conduct on-site clinical audits or internal audits such as report audits and documentation audits.

With the company’s training foundation, we continue to provide training in GCP and other research topics for any clinical research professional. We have written books on GCP for investigators, coordinators and monitors. Our templates for “SOPs for investigator sites” have been sold for over 15 yrs.

Our consulting services include assisting start-up companies with their clinical development plans, providing advice on clinical trials and process and system consulting.

SPRI Ukraine, LLC is a regional full-service contract research organization (CRO), experienced in performing clinical trials in Ukraine. We provide a wide range of research services for pharmaceutical and biotech companies, interested in conducting clinical trials in Ukraine, Russia, and countries of Eastern Europe. We are the integrated team of high professionals with expertise in managing and execution of clinical trials, offering cost-effective and time-sensitive solutions for conducting clinical studies.

SPRI Ukraine offers the high quality services to speed up the clinical development process for your product. Our aim is to satisfy our clients requirements and needs in a timely and cost-effective manner by providing your projects with all the expert support with the emphasis on a priority of patient health status. Below is a list of the services we offer.

-Project Management and Clinical Trial Monitoring
-Regulatory Support/Regulatory Submission
-Legal Assistance
-Logistical Support
-Market Authorization Support
-Finance Management
-IMP and CTM Import, Storage and Distribution
-Investigators Metting Organization
-Feasibility Activities and Site Selection
-Customs Clearance
-Translation Services

(In Ukraine, Clinical Trials Regulations are harmonized with respect to current European Directives and ICH GCP.)

AT CELLCARTA WE ARE DEDICATED TO WORKING WITH OUR PARTNERS TO FURTHER THE LIMITLESS POTENTIAL OF PRECISION MEDICINE

As a global contract research organization (CRO) laboratory, we partner with our clients to address the most complex biomarker and bioanalytical challenges and deliver highly customized testing solutions. With facilities located in Canada, United States, Belgium, Australia and China, CellCarta provides the expertise needed locally to support global clinical trials.

CellCarta offers access to integrated analytical platforms in immunology (immune monitoring), histopathology, proteomics and genomics, as well as sample logistics services.

At CellCarta we are experts at assessing the immune system, whether in the context of oncology, infectious diseases, or autoimmune diseases. With a proven track record in other therapeutic areas as, such as neurological and metabolic disorders, we handle all human biological specimens and deploy relevant technologies to extract valuable information for research and diagnostic applications. We provide assay development and testing services to support a wide variety of translational research, clinical trials, and diagnostic applications.

Committed to delivering the highest quality science and innovation, CellCarta recently acquired Clinical Logistics to expand its specialty specimen logistics and kitting services and Mosaic Laboratories for multiplex immunohistochemistry assays development and deployment.

Reflecting our commitment to quality, our sites hold the appropriate accreditations to support your regulatory requirements, inNeo-Epitope Discoverycluding CAP, CLIA, ISO15189 and ISO13485.

CellCarta is privately held and majority-owned by Arsenal Capital Partners.

AmeRuss Clinical Trials, LLC (headquartered in the US, Arizona) is a next generation CRO that provides comprehensive integrated clinical development solutions to Pharma, Biotech and Medical Device companies.

AmeRuss successfully operates in Russia, CIS, Baltic States, Europe, Caucasia and MENA countries.

We have the capability to conduct full service clinical trials from phase I to phase IV (including observational NIS, registries, Investigator Initiated Studies) and bring the highest quality standards at every step of the trial: protocol design, monitoring, project management, data management, statistical analysis, QA, Pharmacovigilance, Clinical Logistics, GCP trainings, publications, etc.

As a sponsor, you can expect a deep personal attention, flexible approach and a high quality work done within tough timelines.

AmeRuss is a ISO 9001-2008 certified company, and acts in accordance with the international standards and guidance such as ICH GCP, ISO 14155:2011 and other local regulatory requirements.

Please, visit us at:
www.ameruss.com

Forward Clinical Trials, Inc. is a clinical research facility located in Tampa, Florida, and has been actively involved in clinical research since 2013. Our goal is to provide high-quality and timely data in a professional and ethical manner. Forward Clinical Trials (“FCT”) has successfully executed Phase I through Phase IV clinical trials across multiple areas of dermatology and is expanding into internal medicine and rheumatology.

As a quality-driven site, Forward Clinical Trials has established processes to address the increasing complexities of clinical research.


Efficient Start-Up
We understand the necessity to shorten the trial start-up time at the clinical site. FCT has streamlined its processes to meet the ever-increasing demands of enrollment readiness and prompt subject screening timelines with in-house staff completing regulatory submissions, contract and budget negotiations, training, and trial logistics in a collaborative and systematic manner.


Recruitment and Outreach
Our teams work together to develop pre-screening and recruitment strategies to target the population, decrease enrollment obstacles, and lessen the enrollment time. Efforts are made to identify the most productive and cost-effective method specific to the indication, and a recruitment plan is created. The recruitment plan is continually reviewed throughout the trial, and adjustments are made as needed.


Project Management
Trial execution and logistics are coordinated by experienced management involved in all aspects of the clinical trial. This involves working directly with the Investigator and staff to ensure efficient start-up, QA/QC plans, and recruitment/outreach proposals in a productive manner while acting as a direct liaison to the Sponsor and/or CRO.


Protocol Feasibility
FCT performs an internal feasibility review that includes protocol analysis, patient population, trial logistics, and study design to direct identification and selection of trials where expectations are met or exceeded. We understand the importance of the feasibility process at both the Site and the Sponsor level and remain focused on fostering a partnership between our Site and our Sponsors.


Quality Management
The multi-faceted quality management program is designed to shorten data entry timelines and decrease queries while remaining focused on protocol compliance and subject safety.