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Clinical Research Manager

Location:
Washington, DC
Posted:
September 26, 2018

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Beverly Taylor

BEVERLY TAYLOR

**** **** ** ****** *****, MD 21220 PH: 302-***-**** EMAIL: ac66qg@r.postjobfree.com QUALIFICATIONS SUMMARY

Accomplished Business Professional, with over 20 years in Pharmaceutical, Clinical Research Organization and Hospital industry involving clinical research trials; Clinical Research Associate (CRA), Project Manager (PM), Study Coordinator (SC) and Research Assistant (RA) APPLICABLE SKILLS

• Proven expertise in supervising and training of staff

• Implemented project plans, negotiated study contracts and budgets, capable of meeting and exceeding strict timelines

• Highly knowledgeable with U.S. Food and Drug Administration (FDA) regulations, Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines and Company related Standard Operation Procedures (SOPs) EDUCATION

SHAW UNIVERSITY, RALEIGH, NC

Bachelor of Science (Business Management), May 1994 THERAPEUTIC SERVICE AREAS

• Pulmonary Fibrosis-Sarcoidosis-Phase III

• Dermatology- Botox, Acne, Plaque Psoriasis -Phase III,

• Oncology-Head & Neck, Breast, Cervical, Prostate, Lymphoma, Multiple Myeloma, Renal Cell, Non-Small Lung, Non-Hodgkin’s Lymphoma, Brain Cancer- Phases II, III, IV

• Cardiovascular- Intrarenal Abdominal Aortic Aneurysms (AAA), Thoracic Aortic Aneurysms

(TAA) and Penetrating Aortic Ulcers (PAU), Observational Follow-up Study, Congestive Heart Failure, Deep Vein Thrombosis (DVT/PE)-Phases II, III, IV

• Nephrology-Chronic Kidney Disease-Phase IV

• Endocrinology-Erectile Dysfunction, Obesity, Diabetes -Phase III

• Ophthalmology-Cataracts, Macular Degeneration

• Otolaryngology-Allergy, Rhinitis, Sinus Infections-Phase III

• Musculoskeletal- Ankylosing Spondylitis, Femur Fracture, Bone Density, Multiple Sclerosis, Rheumatoid Arthritis- Phase III

• Dental-Periodontitis, Canker Sore-Phases I, II

• Respiratory-Upper Respiratory Infections-Phase II, III

• Central Nervous System-Bipolar Disorder, Alzheimer’s Disease, Dementia, Parkinson’s Disease- Phases III

SURGICAL SERVICE AREAS

Neurosurgery-Aneurysms, Degenerative Disorders, Peripheral Nerve

Plastics-Breast Reconstruction, Rhinoplasty, Mastectomy

Orthopedics- Disc Implants, Spinal Fusion, Laminectomy, Kyphoplasty

Ophthalmology-Corrective and Eyelid Surgery

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Beverly Taylor

Otolaryngology –Cochlear Implants, Sleep Disorders

General/GYN- Appendectomy, Cholecystectomy, GERD, Colostomy, Bowel Obstructions

Urology-Bladder, Kidney, and Prostate Cancer, Female Incontinence PROFESSIONAL EXPERIENCE

NOVELLA CLINICAL, MORRISVILLE, NC

Senior Clinical Research Associate (Remote) Sept 2017 –Current

• Performs on-site Pre-study, Initiation, Interim, and Close-Out Monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff adequately qualified, and site’s activities are in compliance with clinical trial protocol and all applicable governmental and regulatory/ethics regulations

• Complete trip-reports within the assigned timeframe following site visits for Pre-study, Initiation, Interim and Close-out visits, as required

• Review the quality and integrity of clinical study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discuss discrepancies with investigative site staff

• Monitor Informed Consent Forms (ICFs), signed by study patients to ensure that consenting was preformed properly and with the current Approved IRB version

• Communicates with assigned clinical research investigators and staff regularly, documenting the correspondence as per the study specific guidelines

• Document accountability, stability and storage conditions of clinical trial materials as required by sponsor

• Perform Investigational Product Accountability and reconciliation

• Trains investigative site staff as necessary

• Attend team/sponsor teleconferences and/or training on a weekly basis

• Notifies project manager immediately of any suspected fraudulent and/or misconduct activities

• 65-85% travel required

CONTRACTED, DOCS GLOBAL/ICON, NORTH WALES, PA

Amgen FSP Clinical Research Associate (Remote) April 2017 – Sept 2017

• Performs on-site Pre-study, Initiation, Interim, and Close-Out Monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff adequately qualified, and site’s activities are in compliance with clinical trial protocol and all applicable governmental and regulatory/ethics regulations

• Completed trip-reports within the assigned timeframe following site visits for Pre-study, Initiation, Interim and Close-out visits, as required

• Reviewed the quality and integrity of clinical study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discuss discrepancies with investigative site staff

• Monitored Informed Consent Forms (ICFs), signed by study patients to ensure that consenting was preformed properly and with the current Approved IRB version

• Facilitated subject enrollment at the site level with focused patient recruitment strategies and action plans

• Documented accountability, stability and storage conditions of clinical trial materials as required by sponsor

• Performed Investigational Product Accountability and reconciliation

• Identified the sites needs and site related issues, escalate them and/or initiate corrective actions to provide solutions for site staff to facilitate the clinical trial process Page 3 of 11

Beverly Taylor

• Assisted in preparing sites for audits, reviewed audit reports and contributed to resolving findings

• 65-80 % travel required

BOLTON MEDICAL INC, SUNRISE, FL

Clinical Research Associate (Remote) May 2016 – April 2017 (RELOCATED TO MD)

• Performs on-site Pre-study, Initiation, Interim, and Close-Out Monitoring visit activities as assigned to ensure training of site personnel regarding the protocol, study procedures, patient recruitment, retention and regulatory requirements, case report form completion, device accountability procedures, serious adverse event (SAEs), reporting procedures and overall management

• Completed trip-reports within the assigned timeframe following site visits for Pre-study, Initiation, Interim and Close-out visits, as required

• Reviewed the quality and integrity of clinical study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discuss discrepancies with investigative site staff

• Monitored Informed Consent Forms (ICFs), signed by study patients to ensure that consenting was preformed properly and with the current Approved IRB version

• Performed Medical Device accountability and reconciliation

• Provided feedback to assigned sites which included a summary of overall site functioning, detected deficiencies and corrective action needed regularly and followed up with sites until deficiencies were resolved

• Handled site management through frequent contact with the site staff, via telephone and monitoring visits

• Attended study specific Investigator Meeting as required

• 65-80% travel required

NOVUM PHARMA RESEARCH SERVICES, HOUSTON, TX

Clinical Research Associate (Remote) Aug 2015 – May 2016

• Performs on-site Pre-study, Initiation, Interim, and Close-Out Monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff adequately qualified, and site’s activities are in compliance with clinical trial protocol and all applicable governmental and regulatory/ethics regulations

• Complete trip-reports within the assigned timeframe following site visits for Pre-study, Initiation, Interim and Close-out visits, as required

• Reviewed the quality and integrity of clinical study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discuss discrepancies with investigative site staff

• Monitored Informed Consent Forms (ICFs), signed by study patients to ensure that consenting was preformed properly and with the current Approved IRB version

• Documented accountability, stability and storage conditions of clinical trial materials as required by sponsor

• Performed investigational product inventory to ensure return of unused materials to designated location and/or verifies destruction as required

• 65-80% travel required

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Beverly Taylor

PROMEDICA, HICKMAN CANCER CENTER, SYLVANIA, OH (RELOCATED TO TX) Clinical Research Specialist Jan 2015 – Aug 2015

• Main point of contact regarding studies and membership under NRG Oncology, regarding legacy groups, NSABP, RTOG, ECOG and CALGB and the trials offered thru these research bases

• Created and updated Standard Operating Procedures (SOPs), work instructions and internet polices

• Registered and submitted Investigator registration packets to Pharmaceutical Management Branch (PMB) to establish an account with CTEP-IAM, required by the FDA and NCI for participation in NCI-sponsored clinical trials

• Reviewed clinical protocols to ensure collection of data needed for regulatory submission to central and local IRB

• Developed and conducted employee regulatory training UTSW MEDICAL CENTER, DALLAS, TX (RELOCATED TO OHIO) Clinical Research Coordinator Jun 2014 – Oct 2014

• Created and submitted regulatory documents to local IRB for review and approval

• Prepared protocols and detailed summaries for new research studies

• Collected data regarding the management of national research studies from multiple projects, interacting with internal and external research data managers, patients and physicians; regarding tissue samples, lab data, protocols and statistical information on research subjects

• Designed research survey forms to capture participant information to aid in interview process of subjects for research studies

• Developed and monitored budgets, negotiated participant rates, approved expenditures, paid invoices and reconciled accounts

• Monitored and audited regulatory binders for site monitoring visits, to ensure completion and accuracy of patient data

CONTRACTED, ALCON LABORATORIES, INC., FORT WORTH, TX Budgets and Contracts Coordinator Jan 2014 – May 2014

• Developed clinical trial budgets and contracts ranging from $1k and higher in Medidata Grants Manager

• Interacted with clinical Site Management, Trial Managers, Finance, Procurement and Legal daily regarding the status of the study budgets and clinical trial agreements

• Drafted and reviewed clinical trial agreements to be submitted to sites and/or institutions for final execution and approval

• Lead the site negotiation process to finalize the study budgets

• Tracked and finalized the budget and contract progress during study start-up and provided frequent updates

UTSW MEDICAL CENTER, ZALE LIPSHY HOSPITAL DALLAS, TX Surgical Coordinator Oct 2010 – Jan 2014

• Worked proactively with Surgical Nurse coordinators to revise and audit over 1000 procedure cards based on surgical services, under 50 surgeons, within 14 operating rooms; to improve the accuracy of incomplete and erroneous data

• Tracked the inventory of implants, medical devices, instruments and surgical supplies used daily

• Developed, implemented and analyzed reports routinely to identify efficiency trends within the Operating room

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TEXAS HEALTH PRESBYTERIAN HOSPITAL, FLOWER MOUND, TX OR Coordinator Apr 2010 – Sept 2010

• Managed all start-up activities for opening of new hospital to include purchasing, inventory control and stocking for 6 operating rooms (i.e. OR supplies, equipment and instrument sets)

• Assigned all the item numbers for International Classification of Diseases (ICD), Healthcare Common Procedures (HCPs) and codes into Computer Program System (CPSI) database regarding purchasing requisitions, supplies and equipment

• Created vendor contracts, negotiated budgets, and finalized purchasing agreements ranging from

$100k

• Audited patient records, to ensure accuracy in charges for billing of surgical services CHRISTIANA CARE HEALTH SYSTEM, NEWARK, DE (RELOCATED TO TX) Implant Coordinator Oct 2008 – Sept 2009

• Reduced unused implants within the operating room by 60%, to keep with budget constraints

• Handled stocking, inventory and purchasing of implants, according to Operating Room standard polices

• Coordinated medical device vendors meetings weekly, regarding inventory of products within the operating room

• Assured implants were available for all 27 operating rooms and 7 Surgicenter rooms on a daily basis

CONTRACTED, AVID RADIOPHARMACUTICALS, INC. PHILADELPHIA, PA Clinical Project Manager APR 2008 – JULY 2008

• Negotiated study budgets and contract agreements for 15 sites

• Assessed qualifications and capabilities of potential sites/investigators

• Interviewed and screened 6 new hires for contract assignments

• Managed all operational aspects of assigned clinical trails

• Created and tracked invoices regarding Investigator and Vendor payments PHARMANET, INC., WILMINGTON, DE

Clinical Research Associate Mar 2007 – Apr 2008

• Monitored (pre-study, initiation, routine, and close-out visits ) 6 sites for GCP compliance according to PharmaNet SOPs and client guidelines

• Reviewed and processed regulatory packages for Institutional Review Board (IRB) submission

• Mentored and trained over 100 investigative sites during the course of the study

• Negotiated study budgets with investigators, during study start activities

• Presented (study specific guidelines, procedures, CRFs and Monitoring conventions) at Investigator Meeting

• 50-60% travel required

CHRISTIANA CARE HEALTH SYSTEM, NEWARK, DE

Clinical Research Associate May 2006 – Mar 2007

• Handled all regulatory documents, IRB submissions, Case Report Forms (CRFs) and Source documentation for patients enrolled on cancer treatment studies Phases II, III and IV Page 6 of 11

Beverly Taylor

• Reduced Long-term cancer patients lost to follow-up by 90% in 3 months

• Created and developed regulatory documents to support study start-up activities

• Monitored Informed Consent Forms (ICFs), signed by study patients to ensure that consenting was preformed properly and with the current Approved IRB version

• Verified Case Report Forms (CRFs) with Source documentation to track Serious Adverse Events

(SAEs) reported at Investigative sites

• Attended educational workshops and seminars to maintain current knowledge of cancer treatment trends

HEALTHCORE, INC., WILMINGTON, DE

In-house Clinical Research Associate Jan 2005 – Mar 2006

• Conducted site initiation visits remotely, in compliance with GCPs, FDA regulations and SOPs for clinical trials

• Created and developed regulatory documents to support study start-up activities

• Evaluated performance reviews for 5 employees

• Drafted and finalized training materials for new hires

• Point of contact for Investigators, Study Coordinators and project team COVANCE, INC., PRINCETON, NJ (RELOCATED TO DE)

Sr. Clinical Research Associate Aug 2004 – Jan 2005

• Managed operational phases of assigned clinical trial studies according to Covance SOPs, ICH guidelines and GCP

• Evaluated resources and timelines; to resolve study specific issues on a site level daily

• Assumed line management role to assist with training of new CRAs

• Co-Monitored, Initiated and Closed-out clinical investigative sites

• Developed, reviewed and edited project plans (Clinical Monitoring, Safety Management, and Communication plans) for consistency with project goals for 150 sites

• Reviewed monitoring trip reports, protocols, contracts, budgets and site questionnaires for all CRA’s and Project Managers

• Attended study specific Investigator Meeting as required BIO-IMAGING, TECHNOLOGIES, INC., NEWTOWN, PA

Project Manager Oct 2002 – Aug 2004

• Coordinated and managed daily activities associated with the acquisition, processing and read sessions and data output deliverable for the medical imaging component of clinical trials for corporate clients in the Pharmaceutical, Biotechnology and Medical Device industry

• Provided operational support to Bio Imaging’s efforts in the planning, execution and reporting of imaging studies

• Organized and facilitated project meetings related to study activities

• Defined and maintained project timelines, scope of work, budget requirements, service agreements and amendments for 13 oncology projects over all phases

• Managed and negotiated vendor contracts, site budgets and investigator payments

• Submitted in written and oral format, group productivity, project status and key deliverables to senior management on a weekly basis

• Presented imaging requirements and procedures at Client-Sponsored Investigator Meetings, both global and international

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Beverly Taylor

CONTRACTED, HAROLD FARBER AND ASSOCIATES, PHILADELPHIA, PA Study Coordinator Jul 2002 – Oct 2002

• Recruited, screened, enrolled and randomized patients into multiple trails

• Completed regulatory documents, IRB submissions, Case Report Forms and source documentation

• Maintained accountability of all study drug medications and subject diaries CONTRACTED, OMINICARE CLINICAL RESEARCH, KING OF PRUSSIA, PA Clinical Research Associate Jun 2002 – Jul 2002

• Preformed Quality Control (QC) on all final regulatory documents (Informed Consents, Investigator Agreement, Drug Accountability log and Site Initiation docs)

• Coordinated IRB submissions for review

• Primary point of contact for study coordinators, to ensure essential documents were collected within the required timeframe

CONTRACTED, ASTRAZENECA, WILMINGTON, DE

Sr. Clinical Research Assistant Dec 2001 – May 2002

• Reconciled databases for the reporting of outstanding SAEs at the sites

• Handled start-up, trial initiation and training for study coordinators and investigators

• Maintained accurate and up to date information regarding patients in project specific database

(IMPACT)

CONTRACTED, BRISTOL MYERS-SQUIBB, PENNINGTON, NJ

Data Entry Specialist Feb 2001 – Nov 2001

• Performed data entry of patient Case Report Forms (CRFs), according to company guidelines

• Adhered to internal and external deadlines for database locks, for multiple protocols PPD DEVELOPMENT, WILMINGTON, NC (RELOCATED TO PA)

Clinical Research Assistant Aug 1998 – Feb 2001

Contract, Research Assistant Jul 1998- Aug 1998

• Mentored and trained junior clinical team members

• Assisted upper management with project management functions

• Developed collaborative relations with investigative sites and client company personnel

• Prepared and reviewed regulatory document packets for proper content prior to submission to the Project Manager, Central IRB and Client

• Interacted regularly via telephone with investigators, team members and sponsors, regarding project related issues

• Tracked study data (enrollment, adverse events and investigator payments) in (RTMS) database COMPUTER SYSTEMS

• eCaseLink 8.0

• LabConnect, Centralized Laboratory Services

• Canfield Clinical Services

• eCert (Effort Reporting and Certification)

• CTMS 8.0 (Clinical Trail Management System)

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Beverly Taylor

• Siebel

• iMediata Grants Manager

• Mediata Rave EDC

• DataLabs EDC (Electronic Data Capture)

• QDR EDC (Quality Data Services)

• Epic 2012

• CPSI (Computer Program System)

• Oracle/PeopleSoft

• Velos Research

• eIRB (Institutional Review Board)

• eCOI (Conflict of Interest)

• eGrants

• ERGO (Electronic Research Grant Organizer)

• CTSU (Cancer Trails Support Unit)

• IMPACT (International Mission for Prognosis and Analysis of Clinical Trials)

• RTMS (Real Time Multiprogramming System)

• NCI (National Cancer Institute)

• Microsoft Office: Word, Excel, Power Point

OFFICE SKILLS

• Project Management

• Professional Grant Development

• Report Preparation

• Database Administration

• Spreadsheets/Reports/Scheduling

• Professional Presentations

• Records Management

TRAINING/CERTIFICATION

• CITI training for Good Clinical Practices (GCP), Human Subjects Protection (HSP)

• Conflict of Interest (COI)

• HIPAA Research

• IRB Training

• Compliance Ethics

• Code of Conduct

• EDC Training

• Patient Safety

STUDY PROTOCOLS

• Clinical Observational Study of IMLYGIC Use Among Melanoma Patients in Routine Clinical Practice in the United States (COSMUS)

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Beverly Taylor

• Phase 1b Study of Carfilzomib with Induction Chemotherapy in Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

• A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients with Relapsed Multiple Myeloma

• A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500ug Once- Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

• A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

(Device)

• A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms (Device)

• This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft (Device)

• A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta (Device)

• A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection (Device)

• A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery (Device)

• Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis-Phase III

• A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days- Phase III

• A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis-Phase III

• A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)-Phase III Page 10 of 11

Beverly Taylor

• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA)-Axis in Pediatric Subjects (6 to 11 Years of Age) With Perennial Allergic Rhinitis (PAR)-Phase III

• A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Moderate to Severe Atopic Dermatitis-Phase I

• An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment

(MCI) and Patients With Alzheimer's Disease (AD)

• A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade) in Subjects with Chronic Sarcoidosis with Pulmonary Involvement-Phase III

• A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy-Phase III

• A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur-Phase II

• A Phase 2 Multicenter Study of CNTO 328 (Anti IL-6 Monoclonal Antibody) in Subjects With Relapsed or Refractory Multiple Myeloma-Phase II

• A Randomized, Double-blind Pharmacokinetic Study Of Pf-05280014 Plus Taxotere (Registered) And Carboplatin Versus Herceptin (Registered) Plus Taxotere (Registered) And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable Her2-positive Breast Cancer-Phase III

• A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer-Phase III

• A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)-Phase III

• A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer-Phase III

• XIENCE Short DAPT study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) Page 11 of 11

Beverly Taylor

undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents (Device)

• A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to MC2-01 Cream Vehicle and Active Comparator in Subjects with Mild-to-Moderate Psoriasis Vulgaris

• A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)

• A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-2)

• An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines

(SAKURA OPEN-LABEL SAFETY)



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