VolodymyrVeklych, M.D., Sr. CRA
Curriculum Vitae
Eng, Ger<=>Rus, Ukr: BioMedical/Clinical Trials Data translations by Sr.CRA/M.D.
Member of Ukrainian Translators Association
VOLODYMYR VEKLYCH, MD
Tel.: +1 786 474 5953
e-mail: dr_veklych@ukr.net
16919 N Bay Rd, app 408
Sunny Isles Beach 33160,
Florida, USA
DATE OF BIRTH
EDUCATION
http://www.proz.com/profile/1077535
June13, 1973
NATIONAL MEDICAL UNIVERSITY, Kiev, Ukraine, 1991-1999
QUALIFICATIONS
TRANSLATOR / INTERPRETER
PHISICIAN-ANESTHESIOLOGIST
Sr. CRA / Monitor in Clinical Trials
NATIVE LANGUAGES
RUSSIAN, UKRAINIAN
SOURCE LANGUAGES
ENGLISH (translation,proofreading/editing, interpretation)
GERMAN (translation, proofreading/editing)
SERVICES
Translation, editing, proofreading, reviewing, QA, DTP
TURNAROUND
3,000 words a day regular; up to 5,000 words for rush jobs
SPECIALIZATION AREAS
Medical Marketing/Healthcare/Clinical
HARDWARE
2 PC’s with different characteristics
SOFTWARE
Windows XP,SDL Trados Studio, Logoport
EXPERIENCE
Healthcare experience
09/1997 - 08/1999 Resident, Anesthesiology (Main Military Hospital)
09/1999 - 11/2008 Doctor-Anesthesiologist, ICU/OR/ER (Main Military Hospital)
01/2003 - 03/2006 Sales Manager, Medical Equipment (Ultrasound/CT/MRI/Lab)
03/2006 - 09/2009 Sr. CRA/Monitor in global contract organization
Medical translation experience (since 2003)
Freelance medical translator (different translation agencies and direct clients).
Annual volume of medical translations ~ 600 000 words
References, sample translations and detailed project list are provided upon request
Eng, Ger<=>Rus, Ukr: BioMedical/Clinical Trials Data translated by Sr. CRA/M.D.
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VolodymyrVeklych, M.D., Sr. CRA
Curriculum Vitae
DETAILED AREAS OF EXPERTISE
Clinical study documentation
Protocols, case report forms, informed consent forms, investigator brochures, clinical research
reports, quality of life questionnaires etc.
Pharmacy
Medical marketing brochures, technical documentation, tests and methods, pharmacopoeia
monographs, manufacturing process description, drug information, pharmaceutical technology,
pharmacodynamics, pharmacokinetics etc.
Pharmaceutical registration
Drug registration documentation, pharmacotoxicological documentation, periodic safety update
reports, CTD registration dossiers, SOPs, SAE reports, declaration of consent, Summary of
Product Characteristics, adaptation of user’s info, package inserts and labels, patient
information leaflets etc.
Medical equipment
Manuals, specifications, technical characteristics for medical and surgical devices and equipment
Medical software
Manuals, user interface, marketing materials, soft strings
Human medicine
Cardiology, endoscopy, endocrinology, surgery, orthopedics, prosthetics, psychiatry, obstetrics,
gynecology, dermatology, emergency medicine, internal medicine, anesthesia, toxicology,
microbiology.
IVRS and IWRS
Voice prompts, guides, worksheets
PERFORMANCE
Translation = 3000 words/day; Editing = 10000 words/day
Eng, Ger<=>Rus, Ukr: BioMedical/Clinical Trials Data translated by Sr. CRA/M.D.
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VolodymyrVeklych, M.D., Sr. CRA
Curriculum Vitae
IN THE LAST 10 YEARS WERE TRANSLATED INTO THE RUSSIAN LANGUAGE THE CLINICAL
STUDY PROTOCOLS:
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XXX Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer
Phase III study of XXX plus gemcitabine versus paclitaxel plus gemcitabine in patients with unresectable, locally
recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy
XXX Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients
A double-blind, randomised, parallel group, Phase III study to demonstrate equivalent efficacy and comparable safety
of XXX and Herceptin, both in combination with paclitaxel, in patients with metastatic breast cancer.
Phase II randomised, double blind, multicentre study to assess the efficacy of XXX in the treatment of patients with
platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens
Phase III study of XXX plus gemcitabine versus paclitaxel plus gemcitabine in patients with unresectable, locally
recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy
Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of XXX As Initial Treatment for Acute
Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus aureus
A prospective, open-label, non-randomized, clinical trial to determine if XXX improves ambulatory measures in
relapsing-remitting multiple sclerosis (RRMS) patients.
Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of
Immunoglobulin XXX in Primary Immune Thrombocytopenia
A Multi-center, Open-Label, Adaptive, Randomized Study of XXX, a Novel DNA Crosslinker, in Combination with
Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naive
Patients with Extensive Stage Small Cell Lung Cancer.
A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of XXX Compared with Trastuzumab in
Subjects with HER2 Positive Early Breast Cancer
A Phase IIb, Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose-Ranging Study to Investigate the Safety,
Tolerability and Efficacy of XXX in Type 2 Diabetes Patients Not Adequately Controlled with an Optimal Dose of
Metformin Monotherapy
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of XXX in Patients With Acute Mania
Associated With Bipolar I Disorder
Randomized, Placebo-controlled, Double-blind Phase 1b/2 Study of XXX in Combination With Erlotinib in EGFR
Treatment Naïve Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One
Prior Chemotherapy
A Multinational, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety
of XXX in Patients with Major Depressive Disorder.
Randomized, double-blind, comparator drug-controlled multicenter phase IIa trial, based on the results of refresher
course of XXX drug, used in a two dosages for treatment of patients with rheumatoid arthritis
A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy of Increasing Doses of XXX
Extended Release Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients with Multiple
Sclerosis
A one year, open label, dose escalation study to evaluate the long-term safety of XXX extended release tablets in
multiple sclerosis subjects with spasticity.
A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term
Safety and Tolerability of XXX 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)
A Therapeutic-Equivalence Study Comparing the Efficacy and Safety of Intravenous XXX and Epoetin Alfa (Amgen) in
Patients with Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
A Therapeutic-Equivalence Study Comparing the Efficacy and Safety of Subcutaneous XXX and Epoetin Alfa (Amgen) in
Patients with Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
Eng, Ger<=>Rus, Ukr: BioMedical/Clinical Trials Data translated by Sr. CRA/M.D.
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VolodymyrVeklych, M.D., Sr. CRA
Curriculum Vitae
 A Phase III, Open-Label, Multicenter, Long-Term Safety Study of Intravenous XXX in Patients with Chronic Renal Failure
Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
 A Phase III, Open-Label, Multicenter, Long-Term Safety Study of Subcutaneous XXX in Patients with Chronic Renal
Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
MONOGRAPHS:
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Colloidal Volume Replacent Therapy
First steps in EVAR – a clinical guide
Contrast-enhanced ultrasound
Materials for exhibition “Human body” in Ukraine
Eng, Ger<=>Rus, Ukr: BioMedical/Clinical Trials Data translated by Sr. CRA/M.D.
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