Vidya Suryvanshi provides her resume detailing over 12 years of experience in clinical and preclinical research. She has worked as a monitor for various CROs in India, managing approximately 95 projects related to bioequivalence studies, clinical trials, and audits. Currently, she works as a consultant providing global services in clinical research. Her experience includes protocol review, auditing facilities and data, and project management. She holds an M.Sc. in Biochemistry and lists skills in MS Office, communication in English, Hindi, Marathi and Telugu, and experience in toxicology studies and clinical pathology.

1. Vidya Suryvanshi Email: Vidya.vp@gmail.com
Clin-vivo Clinical Research Services
004, Manasa Medows, Rd No. 5 Contact No.: +91 9849639063
Krishana Nagar, Moula Ali,
Hyderabad -500040, TS, India
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PROFESSIONAL EXPERIENCE:
Around 12 years of qualitative experience in Clinical and Preclinical Research
 As a member of preclinical and clinical research team, successfully handled various studies
(eg.BA/BE and clinical trials) for submission of different national and International regulatory
authorities.
 Having enough awareness to various regulatory guidelines GCP, GLP, GMP requirement for
smooth and quality work in the field.
 Given Training of various regulatory guidelines like GCP, GLP.
 As a lead auditor conducted audits of various CROs with international clients.
Clin-vivo Clinical Research Services, Hyderabad. (Website: www.clinvivo.co.in)
Currently providing global consultancy services in the area of clinical research for Indian and
International sponsors.
Projects monitored: Approximately 95 projects
Job description:
 BA/BE study and clinical trial monitoring and management.
 System and facility audit of CRO, diagnostic laboratory.
 Protocol, ICF, CRF and TMF review.
 Complete support to review bioanalytical method development, method validation and subject
sample analysis data.
 Site Master File review.
 Retrospective audit of clinical, bio-analytical, PK, statistical data and reports.
 Follow-up for closure of study related observations.
 To maintain good communications with the Sponsors, CRO, Hospitals while monitoring the study.
Type of studies monitored:
 Crossover bioequivalence studies.
 Parallel bioequivalence studies.
 Reference scaled average bioequivalence studies.
 Bioavailability Studies
WORK EXPERIENCE:
I. Organization: Pharma Edge Centre (I) Pvt Ltd., Hyderabad.
Designation: Monitor
Period: Aug 2010 to Aug 2012.
Projects monitored: Approximately 75 projects
Job description:
 System and facility Audit.
 BA/BE studies monitoring.
 Retrospective audit of clinical, bio-analytical, PK, statistical data and reports.

2. Vidya Suryvanshi Email: Vidya.vp@gmail.com
Clin-vivo Clinical Research Services
004, Manasa Medows, Rd No. 5 Contact No.: +91 9849639063
Krishana Nagar, Moula Ali,
Hyderabad -500040, TS, India
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II. Organization: Vimta labs Ltd., Hyderabad.
It is a well-known CRO as well as CRL approved by various regulatory authorities like WHO,
NABL.
Designation: Group Leader - Quality Assurance Department.
Period: Feb 2010 to Jul 2010.
Job description:
 To assist Manager-QA in monitoring the activity of QA department and during external
audits from sponsor/regulatory agencies.
 Project management.
 Guide and monitor QA auditors.
 In-process and retrospective audit as per GLP and GMP.
 In house system and facility Audit.
 Audit of different type of analytical and bio-analytical method validation and subject sample
analysis.
 Archival of project related QA documents.
Assignments accomplished:
 Have successfully faced audits from DCGI, USFDA, CAP and external audits from monitor or
sponsor.
III. Organization: Clinical Research and Bio-sciences (CRBio), Hyderabad
It is a branch of RA Chem Pharma group, DCGI approved CRO conducting BA/BE studies.
Designation: Sr. Executive - Quality Assurance Department.
Period: July 2007 to Jan 2010
Job description:
 In-process and retrospective audit of bio analytical and clinical phase includes review of
protocol, ICF, screening documents, CRF and Reports.
 In house system and facility audit.
 Outsourced Vendor evaluation.
 Preparation and review of SOPs, method SOPs according to the regulatory requirements.
 Control of the master documents and archival of documents as required.
Assignments accomplished:
 Have successfully faced audits from National and International regulatory bodies like DCGI,
MOH, BPFK, USFDA, EMEA.

3. Vidya Suryvanshi Email: Vidya.vp@gmail.com
Clin-vivo Clinical Research Services
004, Manasa Medows, Rd No. 5 Contact No.: +91 9849639063
Krishana Nagar, Moula Ali,
Hyderabad -500040, TS, India
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Responsibilities:
 In process and retrospective raw data audit, clinical and bio analytical report audit as per GCP,
GLP guideline and applicable regulatory requirements.
 Conduct in process audit for Pilot and Pivotal studies and communicating to the Project In charge/
PI any discrepancies observed through immediate audit reports and verification of implementation
of audit taken.
 Audit of contractual diagnostic laboratories, hospitals and preparation of audit report for same.
 Conducting of system and facility audit of clinical and bioanalytical laboratory at a periodic
frequency to identify and communicate any attention needed via discussions / meeting
(if needed) to the concerned department Head.
 Periodic review of calibration certificates of calibrated instruments in bioanalytical and clinical
department.
 Maintain the quality manual, site master file.
 Maintain and review of training records of all verticals.
 Management of SOPs and change controls for SOPs.
Achievements:
 Inputs based on compliance to guidelines and regulations given to improve existing processes,
approved and appreciated.
 Continual suggestions of innovative ideas for internal systems for the documentation of
bioanalytical and clinical operations.
IV. Organization: INTOX Pvt. Ltd., Pune, Maharashtra, India.
Designation: Scientist (Clinical Pathology Dept.)
Period: July 2003 to December 2004.
Job description:
 Conduct preclinical drug trails and field trails in the field of Toxicology, Pharmacokinetic,
Pharmacology, Immunology, etc.
 Supervise analysis of hematology, biochemical and immunology parameters of experimental
laboratory animals and human samples.
Projects/studies Handled:
(Toxicity, Pharmacological and Pharmacokinetic Studies)
 Oral and dermal toxicity studies (acute/sub-acute/90days).
 Intra-peritoneal/ intramuscular toxicity studies and acute Chicken/ Fish toxicity studies.
 Custom made sub-acute parental toxicity studies.
 To study anti-pyretic/anti-diarrhea/anti -obesity/ anti-inflammatory / anti-stress/ anti-diabetic/
anti-ulcer effect of test drug in laboratory animals.

4. Vidya Suryvanshi Email: Vidya.vp@gmail.com
Clin-vivo Clinical Research Services
004, Manasa Medows, Rd No. 5 Contact No.: +91 9849639063
Krishana Nagar, Moula Ali,
Hyderabad -500040, TS, India
4 of 5
 Pharmacokinetics studies of test drug in rats and rabbits.
Other Responsibilities:
 CPCSEA documentation for different projects.
 To make study plan according to standard guidelines like OECD and GC. Arrange the animals of
suitable specification; distribution of responsibilities and duties.
 Implement Standard Operating Procedures (SOP’s) as per GLP requirement. Validate the
procedures used in various pre-clinical toxicity experiments.
 Maintain quality of outgoing protocols and reports from the section. Plan and execute all the
studies and related works.
 Compilation of data and report preparation.
Other Research Experience:
 M. Sc. Project: At Biochemistry division, Department of Chemistry, University of Pune, Pune.
(Under supervision of Dr. S. V. Amarapurkar)
Worked on a project title “Isolation, Purification and Modification Studies of Poly
phenol oxidase from Banana Pulp”
 At National Chemical Laboratory, Pune, (Under supervision of Dr. Moghe P. P.)
Worked on project title “Waste water treatment".
QUALIFICATION
 M. Sc. (Biochemistry) from Dept. of Chemistry, University of Pune, Pune during 1998-2000.
 B.Sc. (Chemistry) from University of Pune, Pune during 1995-1998.
Training and workshops Attended:
 Successfully completed three months training in Regulatory Affairs at Derbex Labs,
Hyderabad, during 04-Aug-2011 to 04-Nov-2011.
 Attended seminar by Jilla Breeza from Novartis Pharma, on “Hosting a Regulatory Agency
Inspection” on 29 Mar 2010 in Hyderabad.
 GLP and GCP Training program conducted by Biosphere Technology Pvt. Ltd. Goa, on 25 Feb
2009 and 26 Feb 2009 in Hyderabad.
Software Skills:
 Skilled in Use of MS office (MS word, Excel, outlook and power point) and Internet.
Communication skills:

5. Vidya Suryvanshi Email: Vidya.vp@gmail.com
Clin-vivo Clinical Research Services
004, Manasa Medows, Rd No. 5 Contact No.: +91 9849639063
Krishana Nagar, Moula Ali,
Hyderabad -500040, TS, India
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 I have very good oral and written communication skills in English, Hindi and Marathi and oral
communication skills in Telugu.
Personal details:
Name : Vidya Suryvanshi
Date of Birth : 18-Aug-1977
Marital Status : Married
Nationality : Indian
Reference:
References will be provided on request.
Declaration:
I hereby declare that the information given above is brief and genuine to the best of my
knowledge and brief. If you will give the opportunity to work in your organization, I will put my best
efforts.
Date: 15/06/2016
Place: Hyderabad Vidya Suryvanshi