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SYNCORP Clincare Technologies (P) Ltd. India Office: Telangana - Hyderabad Branch: No.301, 3rd Floor, Vijetha Classic Empire, Beside ICICI Bank, Chaithanyapuri, Dilsukhnagar, Hyderabad - 500060, INDIA Tel: +91-9014308214/+91-8125282162/ +91-40-49505611 Novel Business Centre No. 10, 100 Feet Ring Road, BTM Layout 1st Stage. Bangalore - 560 068 (INDIA) Tel: 91-080-65474772 / 91-080-50072226 E-mail: [email protected] Visit us at: www.syncorp.in and www.syncorp.org Regional Office: Corporate Office: Odisha - Bhubaneswar branch: Syncorp Business Center Plot No. F29 (Near Aroma Institute) P.O. BJB Nagar (Behind BJB College) Bhubaneswar- 751014 (Odisha), INDIA Tel: +91-0674-2431877/ +91-9861268508/ +91-9861566969

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SYNCORP Clincare Technologies (P) Ltd.

India Office:

Telangana - Hyderabad Branch:No.301, 3rd Floor, Vijetha Classic Empire, Beside ICICI Bank, Chaithanyapuri, Dilsukhnagar, Hyderabad - 500060, INDIATel: +91-9014308214/+91-8125282162/ +91-40-49505611

Novel Business CentreNo. 10, 100 Feet Ring Road, BTM Layout 1st Stage. Bangalore - 560 068 (INDIA)Tel: 91-080-65474772 / 91-080-50072226E-mail: [email protected] us at: www.syncorp.in and www.syncorp.org

Regional Office:Corporate Office:

Odisha - Bhubaneswar branch:Syncorp Business CenterPlot No. F29 (Near Aroma Institute) P.O. BJB Nagar (Behind BJB College) Bhubaneswar- 751014 (Odisha), INDIATel: +91-0674-2431877/ +91-9861268508/ +91-9861566969

AboutSyncorpSYNCORP Clincare technologies (P) Ltd. (www.syncorp.in) was established in the year 2010 and we are serve Pharma/Biotech companies, CROs, KPO/ BPOs with wide range of best clinical consul�ng and service solu�ons. Syncorp is fastest growing organiza�on has it ’s presence at Bangalore as a Head Quarter and have other clinical business units in

Hyderabad and Bhubaneswar in India.

SYNCORP educa�onal trust (www.syncorp.org) is associated with the University of Mysore offers Master Degree in Clinical Research, other Diploma Course, PG Graduate Programs and Professional skill development programs. OurVisionA leading consul�ng and contract research organiza�on driven by knowledge, integrity and performance commi�ed to our clients success.

OurMissionOur purpose is to enable our customer businesses to manage their services tailored to meet the specific and ever-changing business challenges. Build shareholder value by delivering pharmaceu�cal and healthcare products, services and solu�ons in innova�ve and cost effec�ve ways by consistently enabling businesses to produce superior opera�ng results.

Syncorp’sUSP

1. Our team and consultants have decade plus year of experience in Clinical consul�ng and services sector.

2. Strong Clinical Trial sites management capability to support global trials in India, including eastern part of India.

3. Strong team with Interna�onal and Indian Regulatory experience in wri�ng regulatory documents for USFDA, EMA and DCGI submissions.

4. Exper�se in academic scien�fic wri�ng. 5. Team’s exper�se in clinical research, discovery and pre - clinical research, diagnos�cs

and other health care services. 6. Manpower consul�ng/ Resource management system in place to assist our customer in

their talent acquisi�on strategy – we have large diverse profiles database. 7. Our learning and development academy affiliated to University of Mysore. 8. Large pool of Industry experts in our teaching academy. 9. Customized Learning Management system, to support the con�nuous skill

development of the staff and individuals

MainGoal:Syncorp Clincare Technologies (P) Ltd., established in 2010 has emerged as one of the fastest growing service provider in life sciences and healthcare sector. It provides services in Manpower Consul�ng, CRO/SMO Services, Educa�on/ Training & Clinical Solu�ons. Our Goal is serve our clients and emerge as one of the leaders in life sciences and healthcare sector.

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SyncorpClincareServiceOfferings Snapshot

Service Line Manpower Consul�ng

CRO/SMO Services

Educa�on/ Training Clinical Solu�ons

CROs/ BPOs/ Diagnos�cs/ Health care

· Fresher

· Lateral Hiring

· Leadership Hiring

· Clinical trial site management

· Clinical Trial Monitoring

· Staff Trainings

· Corporate trainings- GCP/ GLP/ ISO Quality Training

Data Services

Sta�s�cal services

Pursuit Management-RFP/ RFI consul�ng

CRO/ SMOs- Business Process Re-engineering

Quality Management Consul�ng Services - CRO/ SMO/ Pharma/ cGMP

GLP/ Diagnos�cs management

PMS study Management

Publica�on Support

Marke�ng Materials prepara�on, Product monograph, Visual Aid, Slides for Healthcare Professional

Product Development materials including graphics designing

Training for sales force

Academics & Healthcare

Professionals

Diploma M.Sc. Programs (Affiliated to University of Mysore)

Manuscript wri�ng

Abstract wri�ng/ Case report wri�ng

Con�nuous Medical Educa�on content Prepara�on

Thesis wri�ng support - course for Pharma/ Life Science/ Medical science/ graduate/ Post Graduate

Sta�s�cal analysis

Resume/ Profiles– Development

Website Designing- Healthcare professionals

Syncorp Clincare Service Offerings

Manpower Consul�ng: We offer services as a consultancy in various ways such as assis�ng the

companies to hire from leadership roles to freshers. We provide customized solu�on to our

customer to support their manpower/ talent acquisi�on strategy requirements, and we work

closely to fulfill the need by ac�vely finding the right skilled individuals from job market and

individual references.

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CRO/SMO Services: We offer a wide range of CRO ac�vi�es related to clinical trials including,

Regulatory submission, Project Management, Monitoring & other SMO services for different

therapeu�c domains.

Educa�on and Training: We offer Diploma courses designed for Life Science/ Pharma science/

Medical science graduates and Postgraduates on key domains of clinical research such as CR,

CDM, PV, Clinical SAS, Medical Wri�ng and Regulatory Af fairs to fulfill the needs of the

pharmaceu�cal industry. We offer M.Sc. (Clinical Research) full- �me course that is recognised

by University of Mysore to educate and train students in depth about ethical and scien�fic

perspec�ves of clinical research.

Also, we offer corporate training at different levels to keep abreast with the updates and train

professionals in GCP, GMP, GLP, Data Services, Quality, Professional skill development training.

Clinical Solu�ons: Our strength lies in providing clinical consul�ng solu�ons for business setups

such as CROs/ BPOs/ pharmaceu�cal & Biotech organisa�ons in Life-science and healthcare.

Our services include :

i) End to end Deal pursuit Management (RFP/ RFI management/ Process reengineering of

CRO/ SMO business processes);

ii) Clinical data Management, sta�s�cal analysis;

iii) Quality management (QA); SOP wri�ng, Qualifica�on audits – ISO, GLP, NABL, CAP &

other regulatory audits; iv) Setup & maintenance of GLP accredited laboratory facility;

v) Medical & scien�fic Wri�ng:

a) Academic Scien�fic Wri�ng:

· Supporting academicians and healthcare professionals in publica�on ac�vi�es

(manuscript, abstract, case study etc);

· Slide prepara�on for con�nuous medical educa�on and doctor’s conference.

b) Commercial-CRO’s/ Pharma Scien�fic Wri�ng:

· Medico-Marke�ng Materials: Content development and designing of

promo�onal materials like product monograph, presenta�on slides and

visual aids etc;

Sales force training manual and training of the sales force;

· Regulatory Wri�ng: Investigator’s Brochure, Protocol, Clinical Study Report,

Case Report Forms for Post Marke�ng Surveillance Studies (PMS);

· Sta�s�cal Support- Bio- sta�s�cal Data Analysis and Sta�s�cal Analysis Plan

and Report Genera�ons.

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CaseStudies

Business Challenges we addressed Our Solution

- - -

Client Profile

· Randomized, Double Blind, Placebo Controlled,

Phase III Study to assess the Safety and Efficacy.

· Dura�on of the study is 2 years with 48 pa�ents

approved by US FDA.

· Site Management ac�vi�es closed on �me with

good Quality.

· Customized, Well governed Project plan & execu�on to correspondence with CRO, Coordina�on between CRO and Inves�gator, Collect and maintain regulatory documents from inves�ga�ve sites, Organize and prepare trial related materials and presenta�ons for Inves�gator mee�ngs.

· Ethi cs Commi�ee submission, Site set up and document

collec�on, Prepare site for SIV, Provide dedicated trained study coordinator to clinical trial site for site works, Independentsite monitoring for quality check of trial documents.

Project Management monitoring, clinical consul�ng solu�ons for CROs for clinical trial including complying with update and train professionals ; irement, GLP and Regulatory requGCP in GCP, GMP, GLP, Data Services and Quality.

Service Profile

· Good turnaround �me in site management & closure ac�vi�es

· Well coordinated site management - without any major escala�ons

· On �me Coordina�on between site and CRO for trial-related ac�vi�es including Ethics Commi�ee submission.

Business Benefits

Global CRO that is part of US based Organiza�on, in business since 1944. It was founded in 2006, is a privately clinical consul�ng solu�ons

for business setups such as CROs/BPOs/pharmaceu�cal organisa�ons owned pharmaceu�cal services company with its business offices in

Los Angeles, CA and Bangalore, India. It has some of industry’s top management and scien�fic talent, along with state of the art R & D

facility in Bangalore, India.

· 67 candidates to be trained in GLP within 15days.

·

Qualify staff in GLP Prac�ces to support regulatory

As agreed delivered the customised trainings in 15 days of �me and supported the customer regulatory audit.

· Customized Training solu�on & execu�on. ·

Staff assessment with GLP cer�fied consultant

·

Par�cipa�on cer�ficate issued to support the audit.

Business Benefits

Service Profile

Business Challenges we addressed

Our Solution

Global CRO (It provides high quality, appropriately priced solu�ons and services with global scalability to life sciences clients addressing their cri�cal business and scien�fic needs. It is designed to deliver high quality and cost effec�ve solu�ons and services for our clients in the Americas, Europe, Asia, La�n America and Australia.)

Client Profile

Corporate training at different levels to keep abreast with the updates and train professionals in GCP, GMP, GLP, Data Services, Quality, Professional skill development training.

audit.

(ii)

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· Skill mappings done for all leadership roles iden�fied

·

Mapped the role within Syncorp database

Target hiring the candidates & short listed the required number

Support customer to roll out offer to candidate and

engage with candidate �ll they onboard.

Business Challenges we addressed Our Solution 10 Plus leadership posi�ons (Sta�s�cal/SAS Programmers

and Biosta�s�cians) to be closed within 45 days to support

immediate ramp up strategy of our client.

·

·

Supported our customer ramp up plan and met client requirement within the scheduled �meframe.

Business Benefits

OurPresence:We offer our services in 3 prominent loca�ons Bangalore, Hyderabad, & Bhubaneswar in India.

· Trial – Randomized, Parallel Group, Ac�ve Controlled,

Open label study to determine the safety and efficacy

(2 Trials) · Dura�on of the study is 1.6 years with 147 pa�ents

approved by DCGI

· Project Management ac�vi�es closed on �me with

good Quality.

· Good turnaround �me in site management & closure ac�vi�es.

· Well coordinated site management - without any major escala�ons. · On �me Coordina�on between site and Sponsor for trial -related ac�vi�es including Ethics Commi�ee submission.

· Customized, Well governed Project plan &

execution to Correspondence with Sponsor, Independent

site monitoring for quality check of trial documents, Routine site monitoring, Study close - out visit Collect and

maintain regulatory documents from investigative sites, Organi ze and prepare trial related materials and

presentations for Investigator meetings.

· Ethics Committee submission, Site set up and

document collection, Prepare site for SIV, Provide

dedicated trained study coordinator to clinical trial

site for site works, Independent site monitoring for

quality check of trial documents.

Business Benefits

Service Profile

Business Challenges we addressed Our Solution

Client Profile

Project Management services for clinical trial Monitoring and site management.s -

Pharma Company (It is fully integrated company, known around the globe for its research and development ini�a�ves and breakthroughs. It is supported by world class manufacturing facili�es accredited with na�onal and interna�onal cer�fica�ons, state

marke�ng network worldwide coupled with dedicated and highly efficient professionals.)

-of -the -art research centre, rich Intellectual Property Wealth, a strong

(iv)

Service Profile

Client Profile

Provide customized solu�on to our customer to support their manpower/ Talent Acquisi�on strategy requirements.

Global CRO (Established and privately held since 1994. It is a leading CRO with mul�na�onal presence in 40 Countries.)

(iii)

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