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
1 of 5
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
2 of 5
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
3 of 5
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
5 of 5
 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