Las Mercedes Medical  Research

Services Business Plan

1. We conduct innovative and impactful research that will improve human health by serving as a hub for scientific discovery and its translation to clinical care. We achieve this by:
2. It creates a new research facility and program focused on biotechnology and translational clinical care.
3. Committing resources to retain our team of talented researchers and capitalizing on investments in our research infrastructure
4. Expanding our nationally distinctive research programs by recruiting over one hundred net new physicians, scientists, and physician-scientists
5. We are building a robust clinical research infrastructure that offers support at all levels of clinical research.
6. We are significantly expanding access to clinical trials by creating a state-wide clinical trials network.
7. Creating a clinical data repository
8. Introduction
9. It is creating and taking a leading position and keeping it competitive, agile, adaptable, and profitable. The research and development concept is one of the earliest stages in creating a business strategy, but the research business success of the entire project depends on its successful introduction. The opportunities to achieve success than those without it. Thus, creating a culture of innovation management.
10. The strategy to get studies (Short and Long term)
11. Gain a competitive advantage. Research with a satellite office in Miami: UM, Innovations Biotech https://innovationsbiotech.com/), Miami Clinical Research https://miamiclinicalresearch.com/ Dr. Hoove,
12. Business growth (Research Phase 1, 2,3,4,)
13. Bring innovation to the project (Become one of the top selected research sites by major pharmaceutical companies, using our reputation, good performance, meeting enrollment goals, and the quality of our time data and recruitment metrics to back up claims.

• Studies completed.
• Randomized patients in less than one month
• Enrollment goals
• Increase profits in the long term

Structure of business

1.   Create SOP and regulations.

2.   Website (Home, About, participate, sponsors/CROs) and emails.

3.   Areas of practices

4.   Facilities and equipment

5.   Certifications and compliance Good standard practice (GSP), IATA, (Certified Clinical Research Coordinator (CCRC), clinical research associate (CCRA), Master Project Manager (MPM), Clinical Ayurvedic Specialist (CAS).

Financial Plan

 

Company Overview

Clinical research is the study of health and illness in people. It is how we learn to prevent, diagnose, and treat disease. Clinical research describes many different elements of scientific investigation. Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients. Clinical trials and research in epidemiology, physiology and pathophysiology, health services, education, outcomes, and mental health can all fall under the clinical research umbrella.

Clinical Trials

A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective. Clinical trials are part of a long, careful process that may take many years to complete. First, doctors study a new treatment in the lab. Then they often study the treatment in animals.

If a new treatment shows promise, doctors then test the treatment on people via a clinical trial.

Clinical Research vs. Medical Care

• A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new.
• People often need clarification on clinical research or clinical trials with medical care. This topic can be incredibly confusing if your doctor is also the researcher. When you receive medical care from your doctor, they develop a care plan just for you. When you participate in a clinical research study, you and the researcher must follow a program called the “study protocol.” The researcher usually can’t adjust the plan for you – but the plan includes steps to follow if you aren’t doing well. It’s important to understand that a clinical trial is an experiment. By its nature, the answer to the research question is still unknown. You might or might not benefit directly by participating in a clinical research study. Discussing this topic with your doctor/researcher is essential.
• Mission: The mission of the Las Mercedes Medical Research is to provide novel modalities across our community
• with comprehensive patient center-care, creating a feasible infrastructure to support research, dissemination, and translation of discoveries to maximize the innovative treatment to our patients leading the growth of our primary care providers’ resources for our scholars; we contribute to new knowledge, discovery, and innovation in Florida, nationally, and globally.
• Our vision is supportive opportunities for pharmacology industry scholars that enable transformative discoveries and innovation, produce new knowledge, and support creative activities for patient benefit.
• Collaboration: Our office advances research and innovation by establishing collaborative relationships at all scales within our community through disciplinary and interdisciplinary collaboration.

Diversity, Equity, and Inclusion: We proactively support creating a diverse, equitable, and inclusive research community. We act upon the deep belief that diverse, honest, and inclusive research environments are fair and just. We prioritize innovation in research, including translating discoveries, public engagement, and disseminating knowledge. Reasoned decisions that are fair and principled and share information transparently. Drugs or treatments are safe and effective. Clinical trials are part of a long, careful process that may take many years to complete. First, doctors study a new treatment in the lab. Then they often study the treatment in animals. If a new treatment shows promise, doctors then test the treatment on people via a clinical trial.We approach current opportunities and challenges with an eye towards the long-term resilience.

• Services:  We provide high-caliber, solution-oriented service to our physicians, and staff to advance their research and scholarship goals while ensuring that activities comply with applicable laws, regulations, and Las Mercedes Medical Research policies.
• Operational structure: Logistic, transportation, and patient center-care.

 

Business Description

• Regulatory start-up and management support for drafting and completing the documents required for study initiation, and for maintaining the regulatory documents throughout the study.
• Clinical research coordinator pool of trained research coordinators available for “hire” on a part-time basis.
• Financial management including support for budget development, clinical trial billing and sponsor invoicing.
• Subject recruitment assistance in assessing feasibility and reaching appropriate subjects.
• Project management including management of multi-site, investigator-initiated studies.
• Clinical research coordinator training and mentoring, full-service training and mentoring services for clinical research coordinators.
• Protocol writing and development assistance with developing and preparing a protocol document.
• Study start-up support in preparing for IRB submission with full-service support in CR connect.
• IND/IDE submissions to the FDA oversight and assistance with applications and follow up.
• Clinicaltrials.gov support for registering the study, updating records, and importing study results.
• Research billing support such as billing coverage analysis and Epic billing assistance.
• Electronic support enhancements, improvements and updates of OnCore (Clinical Trials management system), CRConnect (study start-up), Florence (eReg), and EPIC research system.
• Clinical research unit, an outpatient clinical research space, located on grounds in the Kendall, Miami Dade, Homestead, and  Broward County, available to clinical research team for the conduct of study visits.

Education and Mentoring

There are numerous educational opportunities for LMMS research staff of all levels of research experience and understanding, from the novice to the practiced researcher. Online training, classroom education, and individualized mentoring are available to encourage and support clinical research endeavors.

Standard Operating Procedures

Research Standard Operating Procedures (SOPs) were developed, and are maintained and updated as necessary, to provide consistency for designing and managing clinical trials: from initial concept through submission to research committees, recruitment, managing subjects and data, to source documentation and final close-out and archival. They serve as a reference guide for new and existing staff and as an assurance to potential sponsors of the institution’s commitment to rigorous adherence to Good Clinical Practice.

Study Management

There is available guidance for managing the life cycle of your research study.  You can find a place to go and a person to talk to for navigating the processes for designing, initiating, managing and closing out your study.

Study Start-Up

The clinical study start-up process has been improved and automated. Clinical Research Connect is a new workflow application that was developed to support clinical research study start-up activities.  Clinical research staff will use the Clinical Research Connect workflow application to initiate and complete the study start-up process for all studies that require IRB-HSR review. The Clinical Research Connect workflow application assumes that you have a protocol and that funding has been secured.  At some point early in the process you will need to complete questions in IRB Protocol Builder as per the usual process.

The workflow system’s functionality includes: single data entry for a number of common data points across various systems, electronic submission to multiple functional areas, smart and proactive validations, automated notifications, electronic signatures, auto-generation of documents, and reporting.  The new automated process will allow everyone involved in the study start-up process to realize increased visibility.

If you have any questions about the process in the system, contact Clinical Trials Office at

Conduct Study

Clinical Trial Billing

EPIC

Good Clinical Practice/ICH

Maintain The IDE: Supplements, Safety Reports, And Progress Reports

Maintain The IND

Time & Effort Reporting

Closing Your Study

The responsible party or study record owner should ensure the status is updated with clinicaltrials.gov.  If applicable, study results may be required to be entered here.

Please refer to FDAAA 801 requirements for additional information.

Closing Your Study with the IRB-HSR

Please refer to the IRB-HSR website for guidance on closing your trial with the IRB-HSR.

If you are involved in research at LMR and you will be leaving LMR, there are some steps you will need to take prior to your departure.

Here is an exit checklist provided by the LMR P

Records Management/Retention

Participate in a Trial

Volunteers in research studies—people just like you—are a critical link in making these discoveries possible. Form to fill out.

The information provided here is intended for anyone in the process of deciding to join a research study at the Las Mercedes Medical Research. We hope the information will help you make the right decision for yourself about being in a research study at LMMS.

Stakeholders Questions?

Resources account application

https://clinicaltrials.gov  (Apply to recruiting and not yet recruiting studies)

https://cctclient.com   (will need to contact and set up account)

https://kerloresearch.com    (will need to contact and set up account)

https://invlocate.comv   contact to get list of current studies

https://www.negronresearchservices.com (will need to contact, introduce FCR and set up account)

I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.