Phase II, III, and IV Clinical Trials

Stamford Therapeutics Consortium (STC) is a privately owned and operated clinical research site specializing in phase II, III, and IV clinical trials for the pharmaceutical and biotechnology industries. Operating as an independent investigational site since its founding in 1994, the company’s sole mission is to conduct the highest quality clinical trials so that new, safe and effective medications can be developed, researched and approved for a variety of indications and diseases.

STC was founded by the late Dr. Paul Dalgin, a rheumatologist, and his wife Judy with the idea that research is an important and required element for the advancement of medical science. Equally, clinical research studies can offer patients access to potentially better, more efficacious treatments. Dr. Dalgin chose the word, “Consortium” in the company’s name to reflect his desire to work closely with other like-minded physicians in the community. His goal was to conduct clinical trials across a range of medical specialties and diagnostic areas. Today, the company reflects the achievement of this objective through its working relationship with a cardiology group, a large multispecialty medical practice, and a team of physicians who serve as sub-investigators for many of its clinical trials. STC still maintains a significant presence in research for the treatment of osteoarthritis and rheumatoid arthritis, a legacy of Dr. Dalgin’s early work. At the same time, STC has continued to expand its research into new therapeutic areas, and year after year the list of specialties grows to accommodate a growing demand and new innovations in healthcare.

In recent years, there has been a growing interest in biological based medications or so-called “large molecules.” The medications are based on the body’s own biological processes, rather than chemical manipulation. They can be created from sugars, proteins, nucleic acids, cells or tissues and can include vaccines, anti-infectives, anti-neoplastics, and pain medication. Biologic medications are not new; insulin has been used as a common treatment for decades. With our growing knowledge of the human genome and new molecular biology techniques, specifically designed and tailored pharmaceuticals are now at the cutting edge of therapeutic advances.

STC has worked with a number of new biologic medications that represent these advancements in pharmaceutical research. Biologic drugs, and especially monoclonal antibodies, are often given to patients via injection, as the digestive process would inactivate many of them. This growing field is gaining momentum in the healthcare industry, because as the research progresses, it’s becoming evident that biologic medications are potentially better treatments for a variety of conditions. STC is proud to be involved with this research and has been involved with both Phase II and III projects involving both intravenous and subcutaneous administration, and the monitoring of these exciting medications.

STC’s highly experienced investigators and research coordinators conduct all studies with strict observance of Good Clinical Practice, or GCP. Good Clinical Practice is an international standard of quality that is defined by the International Conference on Harmonisation and is intended to assure that the safety of study participants and the integrity of study data are of paramount importance in the conduct of any clinical trial. GCP guidelines dictate how clinical trials are to be conducted, and define the roles and responsibilities of sponsors, investigators, and monitors.

Headquartered in a professional office suite located in Stamford, Connecticut, STC is situated near a number of major highways, airports and train stations. STC actively recruits patients from all over Fairfield County, CT and Westchester County, NY. The facility has a spacious patient waiting area, 3 exam rooms, a clinical laboratory, and a private office for monitors. A clinical staff member is always available to assist patients with the utmost care, providing a safe and comfortable environment for cutting-edge medical care.

STC has excellent relationships with many local specialists some of whom are involved as sub-investigators. STC is committed to helping sponsors meet and exceed their patient recruitment, retention, and quality assurance/data integrity goals.

STC is proud to work with top pharmaceutical companies such as: Merck & Co., Wyeth, Bayer Corporation, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer and many small to midsized biotech firms.

Technology

Our clinical trial management systems are fully integrated from social media-based recruitment, text-based appointment reminders, electronic regulatory documents, electronic source documents, and remote monitoring capabilities.

Equipment

We are a fully equipped site with all the necessary equipment to successfully run a clinical trial at both locations. All equipment is calibrated annually. Our Laboratory is CLIA certified and all coordinators are all IATA certified.

• Exam Rooms (4)
• Laboratory
• Centrifuge
• Refrigerator (3) locked
• Secure drug storage
• -20 Freezer
• -70 Freezer
• 12 Lead ECG machine
• Monitoring space with wireless internet
• Radiological Services off site (5 miles)
• CPR certified staff

Drug Storage

Investigational product being used for clinical trials is stored on site in designated locked storage cabinets/refrigerators. Cabinets and refrigerators are located in a double locked and secure space with limited access. Temperature regulated with a 24- hour temperature monitoring system. This system provides an alarm should any temperatures go out of range, to include cabinet storage, freezers and refrigerators.

Contract/Budget

Contract and budget is centralized. The negotiation runs in parallel with IRB submission and Regulatory document completion.

Subject Recruitment

We have our own in-house recruitment specialist who is an expert in subject selection. Most of our subjects are recruited from within our own database. We do use referrals from local physician groups. We also use social media advertisement to increase patient access.

Virtual Trial Compliant

Certified as Virtual Trial Capable sites, allowing pharma to use our sites on a trial with decentralized clinical visits and potentially increase the number of trials being conducted.