STAFF

Our group performs 

• written medical translations

• oral medical translations

• medical writing

• independent file review during audits

The policy of the group limits translations of medical or biological texts to professional physicians or biologists only,  translations of clinical texts - to professional physicians only

Specifically, staff is organized as follows, depending on the education:

Name	Required education	Number of staff	Scope of work restricted to the specified group only	Scope of work additionally authorized to the group
Clinical translators group	·  Physician license ·  followed by a certificate of postgraduate training in a certain therapeutic area ·  experience in international clinical trials	8	Any texts with clinical data/procedures, e.g.: ·       clinical trial protocols ·       clinical sections of Investigator's Brochures ·       source documents ·	According to SOP’s- any other translations to Russian. In practice, given the abundance of clinical texts, their non-clinical activities are restricted to preclinical texts (molecular biology and animal toxicity data)
Medical writers group	·  Physician license* ·  followed by a certificate of postgraduate training in a certain therapeutic area ·  experience in international clinical trials ·  excellent English ·  experience in medical writing	2	Medical writing	Clinical translations and their validation
Preclinical translators group	·  Medical or biological education ·  Experience in laboratory experiments (in vitro or animal toxicity)	4	Not applicable	Molecular biology and animal toxicity data (preclinical Investigator's Brochure sections)
Chemical translators group	Education in chemistry	2	Chemical sections of IMPD’s and descriptions of manufacturing / analytical methods	Certificates of analysis
Non-medical translators group	Education in languages	3	Any non-medical translations to English (e.g. regulatory correspondence)	Any non-medical translations (agreements, Informed Consent Forms and other documents dispensed to patients/laypersons)**
Quality assurance	·  Physician license ·  followed by a certificate of postgraduate training in a certain therapeutic area ·  experience in international clinical trials	2	Updating working instructions, providing training to staff and routine quality control, IT supervision	Not applicable
Contracted audit team members	·  experience in international clinical trials >5 years	4	Independent review as part of audit team members	Internal quality assurance
Technical assistants	Specific software skills, Russian language skills, typing skills	4	Technical assistance to translators (processing dictation to formatted text)	Not applicable
Administrator	Specific software skills, Russian language skills, typing skills	1	Overall project coordination, customer support, routine financial operations.	Technical assistance to translators (processing dictation to formatted text)
Contracted oral translators	Experience of medical  simultaneous translation (>5 years)	up to 6 if needed	Simultaneous or consecutive translation	Simultaneous or consecutive translation
Accounting	outsourced

*Informed Consent Form is formally considered a non-medical text as it must be void of any professional terms. Therefore non-medical translators MAY translate it, but subsequent quality control is still done by a physician.

Oral translations are performed by:

Sergey Nechiporenko (medical simultaneous translations since 1999; Investigators’ meetings since 2003). As clinical research professional, normally working solo at Investigator’s meetings since 2006 (approximately 5 events a month), solo at consecutive translations, usually with some of the below-mentioned partners for parallel sessions or clashing events.

Up to 6 contracted medical simultaneous translators depending on the number of parallel sessions/events to take place