ATC is a leading center for Clinical Research in Puerto Rico, slowly evolving since the year 2000, and intensifying its clinic research since 2005. Our center specializes in conducting health-related research studies in human beings, which follow a pre-defined protocol. The protocol is the 'operating manual' for the clinical trial and ensures that researchers in different locations all perform the trial in the same way in a pre-defined subject population. During these trials the participants, or subjects, who are voluntary and which remain anonymous, are assigned to new, not commercially available, research treatments, and primary and secondary outcomes are measured, where the efficacy and security of the investigational drug is evaluated. The trials conducted at our site are all randomized, and mostly all are double blind, meaning that subjects involved in the study nor the health care provider conducting the study, know which study treatments the subjects are assigned to, thus preventing introduction of bias.
When initiating a clinical trial we recruit study subjects referred from other medical practices, from those answering a newspaper or media advertisement or from patient referrals. We follow all the ethical principles for medical research involving human subjects as is described in the Good Clinical Practices, relevant FDA regulations pertaining to 21 CFR Part II, the Declaration of Helsinki, the Belmont Report, etc.
Our clinical trial team includes doctors and nurses, as well as other health care professionals, who constantly monitor participants throughout and after completing the trial. Our research assistants and physician do most of the work in conducting the clinical trial. Their job can include some or all of the following: providing the local Institutional Review Board (IRB) with the documentation necessary to obtain its permission to conduct the study, assisting with study start-up, identifying eligible patients, obtaining consent from them or their families, administering study treatment(s), collecting and statistically analyzing data, which include analysis of response of vital signs to study drug, collecting pharmacokinetic blood samples after randomization of subject to active investigational drug, etc. Responsibilities in the center are variable: maintaining and updating data files during the trial and after follow-up; communicating with the corresponding IRB, as well as any sponsor or CRO, if applies; drawing blood samples at site, handling blood samples by centrifuging and transferring, and also preparing samples for shipment in regulatory containers to central laboratories that process them. Fedex or UPS services are engaged on a daily basis for shipment of regulated samples under IATA regulations, most of samples shipped in dry ice or ambient on the same day.
Although our subjects do not stay overnight, the idiosyncrasy of our clinical trials which are in the field of diabetes and metabolic and cardiovascular diseases, require prolonged blood testing of several hours, under controlled environments, at times requiring the subject to remain at site the whole day. Other prolonged testing would require subject to return in 24 to 36 hours, like the ambulatory blood pressure monitoring or the continuous glucose monitoring for 3 days where subject’s blood sugar is registered every 5 minutes during a 36 hour period. Frequent electrocardiographic tracings are taken and transferred via telephone line to expert cardiologists in the mainland and when inhaled investigational drugs are studies, frequent pulmonary function tests require engaging other expert health care professionals in that related field. Serious adverse events may require more intensive work-up requiring the use of MRIs, CT scans, tissue biopsies etc.
Our study team also manage clinical study supplies, laboratory kits and study material inventory, storage and retrieval. They maintain satisfactory environmental conditions to assure stability of blood samples and investigational drug and maintain controlled temperatures in refrigerators and freezers to maintain integrity of the study materials. Source and study documents are maintained in secure places and certified scanning into electronic media guarantee its integrity.
The Clinical Trials at our site are conducted in many Phases: Phases 1, 2, 3 or 4, each with a different clinical objective. Currently our center handles multiple studies of Phase 2 and 3, which focus on treating small and large groups of patients in order to evaluate the effectiveness of a new treatment, assess its safety, monitor side effects and compare it with treatments already available. In order to conduct trials at our center we have to be closely supervised by appropriate regulatory authorities, which are called the Institutional Review Board (IRB).
WebDMEMR is a web based electronic medical record which ATC started developing as a tool for clinical research since approximately 2005. It has been in continuous development since then and still more features are being added and planned. It has a patent pending and would be the only known electronic medical record (EMR) with features for clinical investigation. Besides being useful in any physician office or practice, it will be the ideal EMR for academic centers involved in research.
WebDMEMR is an important tool in the success of our center when conducting clinical trials. It allows our clinical trial team to conduct an interdisciplinary evaluation on each of our participants. Also it is an excellent tool for gathering and compiling all the information of trial produced by our team, separating subjects from each study, as well as separating studies from each other. WebDMEMR is a great tool when transferring the information to any sponsors or for distant off site controlled access monitoring from multiple sites.