BAYTOWN RESEARCH INSTITUTE
An overview of Bio-Technology Research
ABOUT OUR COMPANY
In 2009 Baytown Research Institute was created by a group of Healthcare professionals with a vast range of experience and expertise in conducting clinical drug research. Baytown Research Institute provides a vital link between pharmaceutical, and diagnostics Imaging, independent-practice physicians and their vast patient resources. The link expands the scope of clinical research in the community setting, offering visible benefits to our pharmaceutical clients, our selected physicians, and their patients. The results of the research performed through these links provide a way to continually improve healthcare practices for everyone.
BACKGROUND
Our extensive background in academic & hospital base research provided the roots from which our services will grow. Our Clinical Research Network, which now serves communities all over the Houston areas, creates environments where pharmaceutical research proves most effective by tapping into the vast patient resources of our independent-practice physicians. We have proven our ability to recruit primary-care physicians/ nuclear imaging/ internal physicians/ family practice into clinical trails. We have established a comprehensive network of primary care and specialty-care physicians, and we have an experienced team of research coordinators and auxiliary staff to support our studies handing all phases of the research process.
Baytown Research Institute effectively and efficiently coordinates all the detail associated with Phase III – IV clinical trails. Our therapeutic expertise includes but is not limited to:
- Cardiology - Internal Medicine
- Family Practice - Neurology
- Oncology - Pediatric
WHAT WE OFFER
- What Baytown Research Institute offers to its Pharmaceutical clients:
a. We offer the ability to connect with patients of physicians associated with
Practice physicians
b We offer the opportunity to conduct clinical drug trails in the community
settings all over the Houston area.
c. We successfully coordinate and conduct all phases of multi-center studies
locally
d. We can reduce the workload by taking responsibility for identifying study
investigators, enrolling patients, and managing all study activities in a
timely manner.
e. We provide qualified research staff to conduct all phases of clinical drug
trails and diagnostics testing.
f. We offer promotional support to maintain patient accrual
- What Baytown Research Institute offers to its participating physicians and
a. We enable the physicians to increase revenue without significantly increasing their office staff workload.
b. We give physicians the opportunity to introduce new therapies to their patients, establishing the physicians as a leader in the diagnosis and treatment.
c. We provide full indemnification to the physician and the practice and thus take away the risk associated with doing clinical and diagnostic research.
d. We help the physician establish patient trust by offering the newest forms of treatment available
BAYTOWN RESEARCH INSTITUTE AS SMO
a. The rights and well being of human subjects are protected
b. The conduct of the trail is in compliance with the currently approved protocol/ amendment(s) with GCP, and with the applicable regulatory requirement(s)
c. The study team is adhering to the protocol, any amendments that have become effective, and sponsor policies.
d. All requirements imposed by the IRB are fulfilled and necessary re-approvals are obtained on a timely basis
e. Laboratory certifications, test equipment calibration records, and pertinent normal laboratory values are current.
f. Determining whether all adverse events (AEs) are appropriately reports within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirements.
g. Communicating deviations from protocol, SOPs, GCPs and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.
BASIC DUTIES OF THE STUDY COORDINATOR
There are routine duties of the study coordinator, which are common across all clinical studies carried out by Baytown Research Institute. Particular studies may require specific duties of the coordinator. Details of these duties are addressed in various other. mentioned below are some of the duties of the coordinator.
A physician Research Coordinator will:
a. Assist the regulatory department of Baytown Research Institute for submission of
the study documents (eg; FDA Form 1572, Curriculum vitae of research person
involved IRB documents, lab related and diagnostics documents) to the
sponsor/representative and IRB.
b. Prepare site for study related equipment and supplies (eg, storage of the study test
articles CRF’s)
c. Participate in site initiations with sponsor/representatives.
d. Prescreen and recruit patients into clinical trails.
( Clinical Research Coordinator of Baytown Research Institute and the principal
investigator and his/her staff will share the recruitment of the study subjects. The
responsibility of interpretation and patient education will also be shared between
Baytown Research Institute coordinator and P.I. and his/her staff. This process will
Be documented in the source documents and the names added in the site personnel
log )
e. Explain the study protocol to the subject and obtain informed consents.
f. Plan patient visit according to sponsor/representative instructions and protocol (scheduling, follow-up phone calls etc.)
g. Collect and ship the specimen (blood urine etc) perform study related procedure
( vital signs, EKG etc) according to the guidelines explains in protocol and lab
manual.
h. Collect and record clinical data from the source documents to the CRF’s per sponsor/representative’s instructions.
i. Interact with monitors and internal auditors regarding the conduct of clinical trails.
j. Maintain study documents and casebooks per GCP’s (Good Clinical Practice) sponsor/represenatatives instructions.
k. Respond to queries from sponsors/representatives.
l. Conduct interim monitoring visits with the study monitors.
m. Prepare for and conduct study closeout visits with study monitors.
n. Collect, report and document adverse Events and serious adverse events to the IRB and sponsors/representative. ( Details are mentioned in the SOP’s of reporting adverse events)
Dr Atul Sachdev . ( Medical Director) Dr Mathew ( VP )
baytownresearch@gmail.com
Jane Castro ( Project Manager, Clincal Coordinator)
janemgdcare@houston.rr.com
baytownresearch@gmail.com