RESEARCH SERVICE PROVIDER CLINICAL SUPPORT SERVICES HEALTH OUTCOMES SOLUTIONS

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1 RESEARCH SERVICE PROVIDER CLINICAL SUPPORT SERVICES HEALTH OUTCOMES SOLUTIONS Reliability Efficiency Consistency

2 BRACANE COMPANY, INC. IS A CONSULTANCY RESEARCH FIRM LOCATED IN HISTORIC DOWNTOWN PLANO, TX.

3 CONTENT Our Mission 1 Services 2 Benefits of Our Services 2 Company History 3 Services and Experience Training 6 Site Management 7 Clinical Trial Monitoring 9 Clinical Research Consulting 10 Functional Clinical Research Services 11 Temporary Staffing Services 12 Health Promotion and Evaluation 13

4 OUR MISSION We fulfill our clients research needs by providing reliable, efficient and consistent service delivery. We operate with the highest level of integrity and provide high-quality service, while offering an environment of reward and growth for employees. 2

5 SERVICEs Functional Clinical Research Services Temporary Clinical Staffing Health Promotion and Evaluation benefits of our SERVICEs We believe in what we do. Our dedication to serve our clients and others is expressed by our intentional use of time and resources to train our team and others and to serve our communities locally and nationally through volunteerism. Internationally, we support efforts that build capacity and sustainability. 3

6 company history Bracane Company, Inc. was founded in 2002 by experienced industry professionals to dispel the myths of clinical research in minority populations, address health disparities in underserved populations and create an alternative solution to traditional clinical research outsourcing. Bracane Company, Inc. provides clinical research trial services and monitoring of health programs, wellness behaviors and outcomes research. Our team consists of medical and business professionals with decades of experience in their respective areas of expertise. We work with a number of U.S. government agencies and private companies. Our international experience includes health assessments for villages in Ghana and monitoring of clinical research facilities in the United Kingdom and Canada. Our core values have been the pillar of success for Bracane Company, Inc. since inception. We perform high-quality, honest work for our clients. Everything we do must be in our clients best interests internally and externally. We provide the technical expertise, regulatory compliance and current technologies relevant to the businesses we serve. We deliver what we promised when we promised we would. Our associates are proud of the work we do and the people around us. We reinvest in the business, our associates and our communities for long-term sustainability. 4

7 ABOVE ALL, WE CONDUCT BUSINESS WITH INTEGRITY ACCORDING TO HIGH ETHICAL STANDARDS. 5

8 TRAINING We pride ourselves on providing regular ongoing training for our staff and offer a full range of training services to help your organization get the right information and hands-on training to complete your clinical trials with as much precision and efficiency as possible. We can train your clinical research staff to ensure data integrity based on information about this industry, FDA regulations, Good Clinical Practice Guidelines (GCPs), Food and Drug Administration (FDA) code of regulations and other topics important to research professionals from start to finish. Good training is imperative for compliance and exceptional outcomes. Whatever your training needs are, Bracane Company can provide them. 6

9 SITE MANAGEMENT Whether it s training you need or someone to perform the role of a clinical research project manager, Bracane Company, Inc. can assist your organization. We know how essential this role is in the management of effective clinical trials. Do you need any of the following services? Contract Negotiation Negotiation site needs, payment or outsourcing services Contract Management Tracking, oversight and execution of contracting needs Outsourcing Management Maintaining and executing oversight and management of outsourcing staff and services Timeline Tracking Ensuring milestones and deadlines are tracked accordingly throughout the clinical trial Trip Report Review and Submission Managing the visit documentation and accurate submission to the client Quality Assurance Auditing research documents for adherence to compliance standards Let our experienced professionals help your organization with your ongoing quality assurance, site audits and other compliance issues related to site management. Bracane Company, Inc. offers fast principal-investigator selection for efficient study startup and a full staff of experienced researchers who can assist with trial procedures and management. 7

10 AS A FULL-RANGE CLINICAL RESEARCH ORGANIZATION (CRO), BRACANE COMPANY, INC. CAN PROVIDE CLINICAL TRIAL MONITORING FOR YOUR ORGANIZATION. 8

11 clinical trial monitoring With a team of fully trained professionals, we can manage your clinical trials from startup through phase II-IV trials. We also offer complete training and ongoing support for new physicians and study coordinators. We have the expertise and the resources to support your needs, no matter how varied or complex. Do you need assistance with any of the following? Pre-Study/Qualification Visit We can initiate a comprehensive assessment of the clinical research site and staff capabilities, and evaluate the site s ability to comply with FDA regulations, GCP s and general conduct of clinical trials Clinical Monitoring Initiation Visit We can provide a review of protocol, regulatory documents, case report forms, enrollment requirements, investigation drug and responsibilities with regard to clinical trials Interim Clinical Monitoring Visit With a focus on quality, we can conduct ongoing clinical monitoring through a clinical trial. From reviewing compliance needs to ongoing regulatory and protocol adherence, we can assist your organization through all phases of a clinical trial Close-out Visit When a clinical trial is ready for completion, let us perform the final retrieval of all data and review your documentation to ensure accountability 9

12 clinical research consulting We provide a broad range of services to organizations interested in clinical research. As a consulting firm, we specialize in supporting medical professionals working on any aspect of clinical trial services and clinical trial site management. Services include: Clinical Monitoring Clinical Research Project Management We are knowledgeable about FDA regulations and understand the value that this intellectual capital brings to the industry, as well as the impact that clinical research results can have on the future of medication and treatment for various therapeutic areas. We have experience with the following: Diabetes Asthma Hypertension Oncology Women s Health Osteoporosis Pain Management Dermatology Anti-infections Endocrinology Medical Devices Health Outcomes 10

13 Functional Clinical Research Services Bracane Company, Inc. has been providing clinical research consulting since As a consulting firm, we support pharmaceutical/biotech, medical device companies and clinical research organizations (CROs) to execute clinical trials for phase I-IV. Clinical Monitoring Project Management Data Management Clinical Trial Site Identification We are knowledgeable about FDA regulations and understand the value that this intellectual capital brings to the industry, as well as the impact that clinical research results can have on the future of medication and treatment for various therapeutic areas. We have experience with the following: Diabetes Asthma Hypertension Oncology Women s Health Osteoporosis Pain Management Dermatology Anti-infections Endocrinology Medical Devices Health Outcomes 11

14 temporary staffing services Let Bracane Company, Inc. help you with your clinical staff resourcing needs. We provide exceptional service for your success. Our services include interviewing and background checks, including drug screening. We staff the following clinical professionals for our clients: Clinical Research Associates Clinical Project Managers Clinical Data Managers Nursing Staff Medical Assistants Administrative Assistants 12

15 health promotion and evaluation Bracane Company provides a wellness solution to help clients identify and manage employees who are at increased risk of lifestyle-related conditions and high-claim illnesses. Bracane Company s meaningful programs and collaborative services have a direct and measurable impact on the health, well-being and health care costs of clients employees. Our solution is participation-based, and return on investment (ROI) is most effective when employers focus on those individuals with preconditions. Our solution is geared toward keeping those precondition employees from moving to worse states of health. When aligned with an employer s realistic wellness objectives, our plan delivers results. Program services and evaluations include: Health Risk Assessment (HRA) Biometric Screenings My Pathway to Health Employee Web Portal Personal Health Profile Health Coaching 13

16 Certifications Women s Business Enterprise (WBENC) Minority Supplier Development Council Some of our clients Novartis Pharmaceuticals Novo Nordisk Teva Pharmaceuticals Bayer Novum Pharmaceuticals UBC PPD Population Health Clients Orange County Health Department Harris County Health Department Tarrant County Health Department Cigna Texas Health and Human Services Commission Texas Department Family Protective Services Key Contacts Pamela Nelson President/CEO pjnelson@bracaneco.com Ph: Mark Mohair COO Mmohair@bracaneco.com Ph: E. 15TH St. Suite 204 Plano, TX For your next project, consider Bracane Company for our: Reliability Efficiency Consistency