Services

SME Global Medical Adviser-Medical Director Service #1

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Dr. Turner provides SME Medical Advising for Notified Body Technical File Submission Guidance and Gap Analysis for the following documents:

  

CEP

Literature Search Term algorithms (You will need 3-4 search term algorithms patterns for BSI and TUVSUD compliance

Literature search Protocol document

Literature Review Protocol Document

Literature Review Plan Document 

Literature Review Report Document

PMS Plan Document

PMS Report Document

PMCF Plan Document

PMCF Report Document

PMCF Study Plan Document

PMCF Study Report Document (This now critical as the notified body will not renew a certificate unless you show the methodology for a clinical study for MDR compliance)

SSCP Plan

SSCP Report

UDAMED document data


Dr. Turner has developed Notified Body Compliant Template documents for the documents listed above and are available for purchase and/or provided as part of my consulting medical device services for MDR compliance.

 

Contact Dr. Turner for these service at (540) 316-8030 or write to contact Dr. Turner at neuroma7@msn.com





 

SME Global Medical Adviser-Medical Director Service #2

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Dr. Turner provides SME Expert and Medical Writer for Notified Body Technical File Submission Documents  to Include the following documents:

  

CEP

Literature Search Term algorithms (You will need 3-4 search term algorithms patterns for BSI and TUVSUD compliance

Literature search Protocol document

Literature Review Protocol Document

Literature Review Plan Document 

Literature Review Report Document

PMS Plan Document

PMS Report Document

PMCF Plan Document

PMCF Report Document

PMCF Study Plan Document

PMCF Study Report Document (This now critical as the notified body will not renew a certificate unless you show the methodology for a clinical study for MDR compliance)

SSCP Plan

SSCP Report

UDAMED document data


Dr. Turner can perform your medical writing needs for the listed document above or  Dr. Turner has developed Notified Body Compliant Template documents for the documents listed above and are available for purchase and/or provided as part of my consulting medical device services for MDR compliance.  


Contact Dr. Turner for these service at (540) 316-8030 or write to contact Dr. Turner at neuroma7@msn.com



SME Global Medical Adviser-Medical Director Service #3

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 Dr. Turner provides the following SME services for Medical Device companies to include the following:

  


Subject Matter Expert for full CER Gap Analysis for MDD to MDR transition.

Subject Matter Expert for CER writing for Class I, IIa, IIb and Class III medical devices. Therapeutic areas include Orthopedic, Cardiovascular, Neurology, Audiology, Oncology, Cosmetics.


Dr. Turner can provided the following lecture series presentation and training to your organization for the following medical device topics topics:

  

Subject Matter Expert and Lecturer for transition from MDD to MDR Transition and Clinical Aspects of MDR.

Trained CEAR and Deficiency Report  (DR)  document assessment and Clinical Reviewer for Class I, Class IIa, Class IIb, Class III medical devices.

Global presenter of MEDDEV 2.7/1 Rev.4, Transition from MDD and MDR .

Trained medical device reviewer  and presenter for Class I, Class IIa, Class IIb, Class III medical devices.

Trained Clinical Reviewer and presenter for ISO 14155 and ISO 9001

Trained  presenter for Clinical Evaluation Report Writing.

Trained presenter for  medical device Clinical Investigations for compliance with ISO 14155 and MDR. 

Trained presenter for   

Literature search Protocol Document Development

Literature Review Protocol Document Development

Literature Review Plan Document  Development

Literature Review Report Document Development

PMS Plan Document Development

PMS Report Document Development

PMCF Plan Document Development







SME Global Medical Adviser-Medical Director Service #4

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Dr. Turner provides the following SME services for Pharmaceutical Industry to include the following services:Medical Device companies to include the following:   


Subject Matter Expert  services for medical review of all individual adverse event reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness. Develop and provide esubmission reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor, depending on the contract. Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, sponsor, investigator and FDA. 


Perform medical review coding of adverse events and concomitant medications for accuracy and consistency. Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents. 


Provide pharmacovigilance medical surveillance support on Serious Adverse Event (SAE) reporting, follow-ups, including after hours coverage of medical emergencies. Provide medical writing and medical review of the 510(k) submission document. 


As a contract medical director and senior global medical adviser for major pharmaceutical companies and Combat Casualty Care Research programs, I have participated in due diligence internal review of potential new company acquisition data for potential for internal stack holders and provided detailed assessment of external assets, including analyses of technical merit and strategic fit, review of intellectual property status, and the generation of constructive technical feedback for external parties. I have participated in visits to/with external companies and facilitated the communication of technical evaluations to internal and external stakeholders. Dr. Turner ca provide these services for your organization.


 As a medical director, medical affairs director, senior global medical adviser and medical monitor for multiple clinical studies for pharmaceutical companies, medical device companies and the U.S. military Combat Casualty Care clinical research program, I have had the pleasure of participating in multiple  aspects of clinical studies (pre-clinical, phase I , phase II, phase III, thru phase IV,  medical safety reviewer, informed consent development /approval, clinical trial site selection, selection of clinical study software, PI selection, clinical study design development with a variety of therapeutic areas/medical devices, multiple levels of regulatory submission to include medical writing of protocols, informed consent development/approval, literature search/review, DDMAC data review, preparation of NDA’s, IND’s, PUSR’s, development of patient safety narratives, medical safety review of clinical study protocol development, medical consent form development, FDA type C meetings,  regulatory review of Rx/OTC study protocols, regulatory review of Rx to OTC switches,  regulatory marketing claim review, medical assessment/ medical writing participation of NDA’s, IND’s, PSUR’s  for regulatory submission for multiple therapeutics, CMC sections and assisted with the scientific writing and review of a BLA (eCTD), PMA.  Dr. Turner can provide these services for your organization.

  

Specifically for one of my main clinical interest for over twenty years which has been lower extremity limb salvage and wound care. I have participated in several projects that have played a significant role in my career pertaining to limb salvage and wound care. Specifically for wound care I have operated on over 300 lower extremity foot cases, utilized technologically advanced wound care coverage therapies, established net worked of wound care KOL’s, participated in the development diabetic wound care website and CME programs. In addition, I have delivered multiple lower extremity wound care presentations for physicians, nurses, residents and students.  Dr. Turner  can provide these services for your organization.


Several of my consulting projects specifically involved safety data review where I have written in excess of 8,000 safety narratives covering multiple therapeutic areas for different projects and provided pharmacovigilance for these therapeutic agents. Dr. Turner can provide these services for your organization  

 

Contact Dr. Turner for these service at (540) 316-8030 or write to contact Dr. Turner at neuroma7@msn.com 




SME Global Medical Adviser-Medical Director Service #5

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 Dr. Turner provides the following SME services for Medical Communications to include the following services:


Dr. Turner has expertise and extensive medical and scientific writing experience in CME/CE arena, KOL development, therapeutic area slide deck development, medical review of slide decks and advisory board development for the following companies to include: ROCHE, OrthoBiotech, Wound Solutions, Cephalon, Brahms-USA, USA Army Combat Casualty Care Research Program, Reckitt Benckiser (USA and EU), Bruin Biometrics, Idenix Pharmaceutical Company, OrthoWay, OrthoMcNeil, Resodyn Corporation, Avodex Partners, Pharmalink Consulting and Kforce Government Solutions and Himagine Solutions, Inc.


Dr. Turner has provided medical and scientific writing, publication medical writing and project development management for CME-CE programs for the following therapeutic areas: Areas of Clinical Participation History and Current Interest include:


Diabetes and Diabetic Wounds Podiatric Dermatology Dermatology Neurology Pain Management Anesthesiology Regenerative Medicine Gastroenterology Circulatory Dysfunction Ophthalmology HIV-Dermatological Manifestations/Lower Extremity Complications Virology and Bacteriology Osteopathic / Orthopedic Dysfunction Rheumatology Radiology Lower extremity Oncology - Bone /Soft-Tissue Malignancy Pharmacology Pharmacovigilance Monitoring/Reporting Lower Extremity Reconstructive Surgery Foot/Ankle Lower Extremity Venous/Arterial Wounds Lower Extremity Diabetic Wounds Wound Care Therapeutics Infectious Disease Respiratory Dysfunction/Asthma


Dr. Turner has participated in the following medical communication activities  and can provide his expertise and experience to your organization with regards to the following:


Participated as the contracted Medical Director for Combat Casualty Care Research Program (CCCRP) for Regenerative Medicine and Dermatology Program Resodyn Corporation.


Participated as the Medical Director for Combat Casualty Care Research Program (CCCRP) for the S-Ketamine Anesthesia and Analgesia Program Resodyn Corporation.

 Participated in 430 CE dinner meetings, 420 CE teleconferences, and 320 onsite departmental briefings for Cephalon for their CE promotional programs for the active pharmaceutical ingredients AMRIX, Provigil, Nuvigil and Fentora. Traveled to all 50 states twice with this program and delivered these in 320 hospital facilities.


Additional CE activity included departmental briefings for shire for the condition of Ulcerative colitis in conjunction with John Hopkins University, CE activity for departmental onsite briefings for Ortho Biotech for the therapeutic area of Ovarian Cancer treated with DOXIL, onsite departmental briefings for new advances in Advances in ADHD Mediations for School-age Children for Shire, onsite departmental briefings for Evidence-Based Approaches to Post-MI LVD: Clinical approaches for GSK, onsite departmental briefings for the condition of Hypophosphatemia in Stage 5 CKD with therapeutic treatment using FOSRENOL for Shire, onsite departmental briefings for the condition of Hypertension and Comorbidities with therapeutic treatment with COREG, onsite departmental briefings for the condition of Chemotherapy Induced Nausea and Vomiting with therapeutic treatment with Palonosetron HCL Injection for MGI Pharmaceutical Company.


Additional CME activity included onsite departmental briefings for the condition of Idiopathic Thrombocytopenia Purpura for GSK, onsite departmental briefings for the condition or need for solid organ transplantation “Optimizing Immunosuppressive Management Strategies In The Transplant Patient” for GSK, onsite departmental briefings for the condition of Sepsis: Bacterial Infections and Sepsis-Procalcitonin Testing for Procalcitonin Testing, onsite departmental briefings for the condition of Thrombocytopenia- Associated with Chronic Liver Disease with therapeutic treatment with RHuIL-11 and Eltrombopag for GSK, onsite departmental briefings for the condition of Colorectal Cancer” New Developments in Colorectal Cancer Featuring ASCO Updates to include biologic therapies such as Cetuximab, Bevacizumab, Dual Biologics (PACCE Trial), Irinotecan and 5-FU/FA +/- Cetuximab, Crystal Trial, EPIC Trial, XELOX or FOLFOX-4.


In addition, I participated in the development and delivery of CME programs for ROCHE for their breast cancer, colorectal cancer CME programs. We delivered these programs in 260 departmental briefing, office based facilities and 129 dinner meetings for ROCHE.

 With the programs I was assigned to the KOLs selected for these programs, participated in the advisory boards for the development of the slide decks and meeting materials and moderated all of the programs. These programs also included delivery of programs in Puerto Rico and my wife was hired by Cephalon to be a Spanish–English translator for these specific programs present in Puerto Rico.


Contact Dr. Turner for these service at (540) 316-8030 or write to contact Dr. Turner at neuroma7@msn.com