JPD Research, LLC

JPD Research, LLC
Belinda Jones, RN, BSN, President & CEO
3101 Guess Rd., Suite B
Durham, NC 27705 USA
Phone: 919-471-4339
Fax: 919-620-5738
E-mail:
Web: http://www.jpdresearch.com


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Company Overview

    Since 1999, JPD Research has been a full-service contract research organization (CRO) and consulting firm that provides services to pharmaceutical, device, biotechnology and other related companies.

    We will offer our clients a unique experienced scientific insight on all aspects of drug development. Our experienced staff is able to provide clinical, regulatory and medical guidance to companies developing new therapies as well as those expanding the profiles of already marketed products.

    JPD Research has knowledge and experience in several therapeutic areas, taking compounds from the IND phase, phases I - IV, and market approval. We also have experience in interventional research with the National Institutes of Health.

    We can help companies with complex regulatory issues, design overall clinical development programs and develop the strategy for critical decisions.

    We know the importance of designing efficient, cost-effective development strategies to optimize the market potential of our clients . Whether the project involves clinical trial design, CRF development, contract negotiation, monitoring, data management and conduction of the clinical trial, it is our goal to understand the project objectives of each individual company and how to enhance our clients projected aspirations appropriately and effectively.

    The philosophy of JPD Research, LLC is to provide the highest quality of Clinical Research services to our clients. While we develop and maintain a great working relationship at all times, contracting not just according to our costs, but also taking into consideration the cost of our perspective clientele.

    JPD Research, LLC was formed as a sole proprietorship in Durham, North Carolina, by Belinda Jones, RN, BSN.   Ms. Jones graduated from North Carolina Central University with a Bachelor of Science in Nursing and she has served in multiple leadership roles during her career in Clinical Research.

    Over the past 10 years, Ms. Jones has worked with several reputable Clinical Research Organizations such as PPD Development, Duke Clinical Research Institute and Duke University Medical Center's Anesthesiology Research, etc.   Ms. Jones and her staff have spent a great amount of time in the clinical research field in various trials, stages and phases. The Staff of JPD Research has over 30 years of research industry experience collectively.

 

Products and Services

    • Clinical Trial/ Project Management
    • Site Management
    • Trial Budget Management
    • Clinical Research Monitoring of several therapeutic areas with seasoned Clinical Research Associates that have been thoroughly trained
    • Data Management experience in several different entities and knowledge of several databases
    • Contract Negotiation
    • Information Technology
    • Regulatory/Quality Assurance
    • Professional Auditing
    • Electronic Data Capture (EDC)
    • On site developmental training for investigators and staff
    • On site facility assessment
    • Investigator Site Selection Services
    • Customized Programs in:
      • Working with/interacting with Institutional Review Boards (IRB)
      • Understanding and complying with FDA, HHS, NIH and HIPAA regulations
      • Effective subject consent processes
      • Ethics/Protection of human subjects
      • Current industry standards (ICH, GCP, GLP, GMP, CFR )
      • Regulatory document preparation and maintenance
      • Ability to provide multiple, quality sites
      • Ability to provide quality Clinical Research Associates, Regulatory Document Specialist, Quality Assurance, Data Management, Query Resolution, Administrative Assistance, etc.
      • Ability to conduct Phase I-IV, Feasibility, Pivotal, Interventional, NIH and Governmental studies
      • Large database of highly skilled, experienced and enthusiastic Investigators
      • Dedicated, full time, and experienced Clinical Research Coordinators
      • Nationwide coverage
      • Access to large patient populations with cultural diversity
      • Efficient and centralized contract and budget resolution
      • Ability to conduct inpatient, outpatient and critical care studies, etc
      • Strong working relationships with local and central IRBs and laboratories
      • Track record of consistently meeting or exceeding enrollment goals
      • Aggressive patient recruitment program to support local sites own efforts
      • Proven ability to successfully conduct even the most challenging of studies
      • Stable, effective and mutually beneficial working relationships with Investigative sites
      • Unique, customized services for customers participating in our programs
      • Supporting member of ACRP and DIA

    Trial Management

    • Staffing with trained and experienced clinical research coordinators
    • Subject Recruitment Strategies
    • Data Management
    • Independent protocol audits for QA and training purposes
    • Budget negotiations

    Site Management

    • Site specific Standard Operating Procedures (SOP's)
    • Quality Assurance
    • Audit Services
    • FDA inspection preparation

    Site Business Development and Promotion

    • Notification of upcoming research trials and opportunities
    • Marketing and business development of your site and its capabilities

 

Facilities

    We Provide excellent services to our clients. One of our largest assets is that we are a small CRO and Site selection Services that can cater to our clients needs without having to use expensive applications already purchased for JPD Research clinical trials. We are able to adapt to our customers needs and not have to many persons overseeing and contacting the Sponsor or sites. We have the ability to streamline our practices to meet most needs of our clients. However, we will adhere to all guidelines set forth for clinical research that has been previously stated in Products and Services section.

 

Clients & Companies

    We have sucessfilly worked with the following companies:

    • Duke University Medical Center Anesthesiology Department
    • Duke Clinical Research Institute
    • Salix Pharmaceuticals
    • CardioMems
    • Medifacts International
    • Adolor
    • BMS
    • Gilead Sciences
    • Johnson & Johnson
    • Parexel
    • Icon
    • Ammlung Milto & Associates
    • West Houston Clinical Research
    • Borice Willis Clinic
    • Southern Heart Specialist
    • Monitor for Hire
    • Clinforce
    • Sneed Clinical Research

    And a wealth of other companies.

 

Efficency

    Since we utilize our database to identify investigators based on your specific criteria, a significant amount of your time and resources are saved during the initial site identification, screening, and qualification of our investigators.

    Because of our ability to present multiple sites, one call to us can assist you in selecting investigative sites. You are always free to select only those sites that you want to use. All sites must demonstrate their own merit for selection and do not expect to be chosen just because they are part of the our network.

    Budgetary and contractual discussions are always centralized, helping to minimize lengthy negotiations for each site. Upon agreement of a budget (which is applicable across all sites), a clinical trial agreement can typically be executed within one week or less without forseen complications.

 

Services and Experiences

    Our Company JPD Research has been involved in the following therapeutic areas:

    Anesthesiology, Trauma, Transplants, Renal, Infectious Diseases, Ophthalmology, Oncology, Cardiology, Endocrinology, Gastroenterology, Dermatology, Gynecology, Sepsis, Critical Care, Pediatrics, Psychiatry, CNS, Respiratory, Devices and Interventional NIH and Government funded studies.

    With the following Indications:

    Clinical research experience includes Dosage Inhaler, Dialysis Catheter, Computerized Pump, Neurological Stents, Cardiac Sensor device, Several Device, Ichthyosis Vulgaris, Dry Eye, Respiratory, Pain, Post Operative Ileus, Total Abdominal Hysterectomy, Prostate Cancer, Ovarian Cancer, Radical Cystectomy and Urinary Diversion for Bladder Cancer, Cardiology Diseases, Renal, Hepatitis, HIV/AIDS, Sepsis - Critical Care, Irritable Bowel Diseases (IBD), Clostridium Difficle, Phenylketonuria (PKU), Pediatric trials, Schizophrenia, Manic Depressive, Epilesy, Parkinsons and Diabetes clinical trials.

    JPD Research has been involved in several different trial phases with the FDA Phases I, II, III, IV, Feasibility and Pivotal trials and with the NIH we have been involved with high profile Interventional trials.

    Our company has used several different EDC systems either as trial run for systems chosen by the company contracted or used in conjunction with monitoring 100 % or 10% Source Data verification. These are only the systems that JPD Research has used in the past, however members of our staff has used several others. With our combined experience we are capable of choosing a system the will best fit the needs of a given study.

    JPD Research also has access to an Electronic Data Capture solution, which can be built to custom fit your clinical trials needs.

    All staff has the knowledge of:
    JPD Research SOP and WPDs designed to fit their specific Job descriptions, along with:
    Windows 95, Windows 97, Windows 2000, Windows NT, Windows XP, Microsoft Word, Excel, Microsoft Office, Power Point, Adobe Reader, Adobe Writer, Adobe Creative Suite for Macintosh and IBM compatible Software/Hardware, Netscape, Microsoft Exchange, Lotus Notes, Microsoft Publisher, Microsoft Access, PQRS version 3 Site Descriptor (DCRI Application) ClinTrial Database, Oracle Applications, Trial Watch Database, Citrix, Metaframe XP with WebEX, Electronic Data Capture by Trial Master, Quick Study Capture, Data Trak and CRF Image Viewer.

    We have staff to perform the following task levels:

    • Project Management
    • Budget Creation and Management
    • Clinical Research Associates/Monitors
    • Research Assistants
    • Site Management
    • Accounting
    • Legal Counsel
    • Data Management
    • Review of AE/SAEs
    • Medical Physician for SAE Review
    • Regulatory Documentation Review
    • Quality Assurance

    Site Recruitment, Selection and Retention Specialist:

    A Database of over 400 Physicians and Study Coordinators, with the ability qualifications and experience to perform in wide variety of therapeutic areas in clinical research that JPD Research, LLC and affiliates has worked with in the past.

    We offer an elaborate class for training of Study Coordinators for any therapeutic area.

    Because we are a small CRO we can also offer customized, cost effective solutions to our clients to get their product to the market quickly, effectively to ensure great concentration to detail for superior quality and results.

 

Investigator Services Offered

    JPD Research will seek out and find clinical trials for chosen sites. We would like for you to participate in the new and upcoming clinical trials by joining our Network of Investigators. JPD Research, LLC is a is an Innovative Country Wide Site Selection Service Organization providing quality services to US investigators, private and group practices, hospitals, NIH and healthcare related organizations in the United States with possible global expansion within the next 1-2 years.

    JPD Research, LLC has been successful in primarily obtaining studies from the nationwide sponsors and CRO's for investigators and we will also help your site pre-qualify for new clinical trials in phase I-IV, inpatient and out-patient, whether pharmaceutical or medical device and combined product clinical trials in all patient populations.

    JPD Research, LLC is interested in establishing a mutually beneficial relationship with your site to enhance your exposure with sponsors and CRO's nationwide, with a potential to eventually expose sites globally, allow sites to receive current and upcoming quality clinical trials on a priority basis.

    JPD Research, LLC offers sites the right to accept or reject any study offered by us.

    JPD Research, LLC also offers the following services to the investigators, private and group practices, hospitals, and healthcare related organizations: Services for Investigators, Patient Recruitment strategies, Physician Practice Management, Consulting Services, Help with training on Electronic Data Capture (EDC), Inter-Active Voice Response(IRVS) applications and Management, Staffing Services, Training of Staff, Site Start up, Regulatory Document review and submission to the Sponsor and/or your Institutional Review Board.

 

Therapeutic areas

    • Anesthesiology
    • Trauma
    • Transplants
    • Renal
    • Infectious Disease
    • Psychiatry
    • Central Nervous System
    • Ophthalmology
    • Oncology
    • Cardiology
    • Endocrinology
    • Gastroenterology
    • Dermatology
    • Gynecology
    • Step-down
    • Sepsis
    • Critical Care
    • Pediatrics
    • Respiratory
    • Drug Accountability Monitor
    • Quality Assurance/Clinical Trial Auditor

 

Contact Information

    JPD Research, LLC
    Belinda Jones, RN, BSN, President & CEO
    3101 Guess Rd., Suite B
    Durham, NC 27705 USA
    Phone: 919-471-4339
    Fax: 919-620-5738
    E-mail:

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Last updated on August 21, 2008

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