SYNCHRON INTERNATIONAL NETWORK

Excellence in clinical research

Welcome to the world of Synchron. Were a company with a rich tradition of serving some of the worlds most successful pharmaceutical companies as they strive to produce new products in the constant fight against illness and disease. We, in turn, continue to serve the industry with our own high standards of clinical trial services. In 2007 the company made significant strides in its bid to expand operations within India and on the international stage. We acquired Innovance, a start-up Ahmedabad-based Contract Research Organisation. Innovance has built an impressive world-class clinical research facility and this acquisition gives Synchron a real edge in offering further, excellent internationallyaccepted clinical research facilities.

Based in India, Synchron Research Services meets specific requirements of clients operating in the clinical We also expanded our footprint with registration of new pharmaceutical a joint venture in Thailand with Bioproducts and medical devices, Innova. The premier Clinical Research from phase I to phase IV, including Organization in Thailand has a 30 bed Bioequivalence, Bioavailability, facility with its own bionalaytical lab. Pharmacokinetic/Pharmacodynamic studies, Statistical Analysis and Data I hope very much that this publication Management. We adhere strictly at all confirms our belief that we offer times to ICH - GCP guidelines. unrivalled expertise across all the critical areas of clinical research. Our services are available to domestic and international pharmaceutical and bio-pharmaceutical companies. Dr. Shivprakash Rathnam, M.Pharm., Ph.D. Founder & Managing Director, Synchron Research Services Pvt. Ltd.

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Indias International CRO

SYNCHRON RESEARCH SERVICES PVT. LTD.

As a leading international clinical research organisation with an outstanding reputation, our principal role is to help clients achieve their research and development objectives with true scientific spirit and compliance in line with international guidelines on Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

Dr. Shivprakash Rathnam, M.Pharm., Ph.D. Founder & Managing Director, Synchron Research Services Pvt. Ltd.
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We have an extensive network of CROs, companies, consultants and individuals who are experienced experts in their chosen fields.

Strategically positioned on three continents, we have a broad perspective and understanding of global issues and local markets. Quite simply, we unravel the present so that you may better understand the future. Synchron conducts clinical trials that are rapid, cost effective and of the highest quality. We adhere to ethical standards and draw upon an international network of experts to meet the specific requirements of clients operating locally and internationally. We offer Phase I - IV clinical trials. These include studies in bioequivalence, bioavailability and pharmacokinetics/pharmacodynamics. We also conduct bioanalysis, statistical analysis and provide data management. Active for 10 years, we have an extensive network of CROs, companies, consultants and individuals who are experienced experts in their chosen fields. These include physicians, clinical pharmacologists, pharmacists, pharmacokineticists and biostatisticians. With quality of paramount importance, we comply with GLP and GCP standards in conducting scientific work. Hence we audit reports, inspect procedures and check data as well as seeking ways to improve our services.

Because we consider ourselves your local global partner, rather than simply a vendor, all our clinical studies also adhere to local regulations irrespective of whether such studies are for local clients or international firms. Synchron won international recognition by associating itself with the world leader in clinical research, PAREXEL International. We are now reaching many more clients in Europe and Southeast Asia with our state-of-the-art facilities in France and Thailand respectively.

Services
Sample size determination Patient randomisation Ethics Committee approval Preparation of CRF manual Data analysis Sample analysis Statistical analysis Feasibility studies PK/PD studies Report writing Quality assurance Post marketing and marketing support trials Drug Device trials

Instrumentation and Facilities

5 x LC MSMS 1 x GC MS 4 x HPLC with UV, fluorescence and electrochemical detector Three clinical pharmacology units, two with 30 beds each, one with 75 beds Physical examination room Sample collection area Intensive care units Dining and recreation areas

Capabilities
Phase I Pharmacokinetic studies Since 1998, we have conducted a wide range of biostudies on healthy adults including males, females, post-menopausal women and special populations. Our work includes bioavailability, pharmacokinetic, pharmacodynamic, bioequivalence, food-effect, drug-todrug interaction and dermatopharmacokinetic studies. Based on a survey of CROs in India, the global growth-consulting company Frost & Sullivan awarded Synchron the title Partner of Choice for Clinical Research (BA/BE studies) in 2005.
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We are in the front line as the winner of the prestigious Indian Drug Manufactures Association research award for bioanalysis in 2003 and 2007.

Monitoring Bioanalysis Our specialists bridge language, culWe are in the front line as the winner of tural and clinical research needs. They the prestigious Indian Drug Manufacare experienced in clinical trials in India turers Association research award for and abroad on behalf of international bioanalysis in 2003 and 2007. Our CROs under ICH GCP guidelines. scientific personnel are experienced in analysing drugs and metabolites in Project Management various biological matrices. We have We aim for comprehensive coverage, published research papers in national aware that precise planning and efficient and international journals. In addition, execution are critical to the success of we have developed and validated each project. Our team meets clients methods for various drugs and we particular requirements and gives them continue to do so. real time control of a project by delivering status reports and metric reports. Phase II-IV Clinical Trials Our capabilities include protocol development, feasibility studies, investigator identification, independent ethics committee submission, statistical design and analysis, CRF design and production, clinical equivalence project designs, PK/PD studies, postmarketing and marketing support trials and medical device trials. Clinical Trial Management Our team of experienced and welltrained managers and CRAs are in regular contact with clients, clinical sites, investigators and regulatory authorities to ensure accurate and timely dissemination of vital information. Data Management We offer a wide range of services towards data processing, analysis and management. We also have validated hardware and software for data modelling. With the skills of our data management team and sound infrastructure we have delivered PK/PD modelling and biostatistics to many pharmaceutical, biotechnology and generic companies in India and beyond. Other Speciality Studies We also conduct studies for testing topical products. We have standardized Dermato-pharmacokinetic and Skin Blanching studies as per USFDA guidelines in our lab. We have full capability and facility in conducting glucose clamp studies for testing insulin like products.

Data Management Tools

SAS Oracle 9i MedDRA Kinetica WHO Drug Reference List MedDRA WHO Drug Reference List Oracle 9i Microsoft Products Watson LIMS

Globally Synchron offers

Equipment 7 x LCMSMS 1 x GCMS 8 x HPLC with all detectors 175 beds 14 beds Phase I unit Tools Kinetica WinNonlin SAS MedDRA WHO Drug Reference List Oracle 9i Microsoft Products

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The Premiere Clinical Research Organisation

BIO-INNOVA & SYNCHRON CO., LTD.

Bio-Innova and Synchron Co., Ltd. is Thailands first private clinical research organization (CRO), established in Bangkok since 2006. Our company brings a global network, advanced research technologies and international standards to Thailand and Southeast Asia.

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Dr. Sasitorn Kittivoravitkul, B.Pharm., M.Sc.,Ph.D. Managing Director, Bio-Innova and Synchron Co., Ltd.

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Our team delivers our sponsors clinical project throughout drug development stages with quality, speed and cost control.

We are currently one of the most technologically advanced and fastest growing companies in Thailand. Our commitment is to best serve our clients in the areas of clinical research, such as clinical trial phase I-IV, pharmacokinetics, bioavailability, bioequivalence, statistics and data management. Our well trained and experienced professional team, which includes medical doctors, nurses, pharmacists, bioanalytical scientists and biostatisticians, works in compliance with ICHGCP, ISO/IEC 17025 and OECDGLP. Many drugs, including highly sensitive compounds such as hormones, have been developed and validated within our laboratory by our experts and experienced scientists. We regard clients as our close business collaborators and, with this in mind, we play an important role in supporting them to speed up the time of products to market, minimizing study cost and risks whilst at the same time maximizing return on investments with high standards, quality and flexibility.

Our Services
Bio-Innova offers full range of clinical trial services. Pilot and Pivotal Bioequivalence Bioavailability Phase I-IV clinical trials Pharmacokinetics Pharmacodynamics Dermatopharmacokinetics Food interaction Drug interaction Evaluation of drug delivery system Cosmetic trials Herbal trials Regulatory affairs Translations

Clinical Trail Phase II-IV

Our team delivers our sponsors clinical project throughout drug development stages with quality, speed and cost control. Project management Protocol development Feasibility study Investigator identification Regulatory approval Ethics committee approval Clinical monitoring Safety & pharmacovigilance Patient recruitment Data management Biostatistics Regulatory affairs GCP training courses Technology services

Clinical Trial Phase I & Bioequivalence/ Bioavailability Services

Our comprehensive services embrace protocol development to final study reports and are in compliance with ICH-GCP, ISO/IEC17025 and GLP requirements. Protocol development Regulatory approval Ethics Committee approval Study population Clinical study Analytical method development and validation Bioanalysis Data management and statistics Report writing and submission Quality assurance

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We have developed and validated methods according to US-FDA guidelines for various drugs using high technology and validated equipments.
Clinical Facilities Data Management and Statistics Services

Our modern 30-bed in-house facility accommodates clinical trials, bioavailOur skilful and experienced staff offer ability and bioequivalence studies with evaluation of study results for pharmaspecial care and treatment from our cokinetics data modeling, statistical well-trained medical professionals. analysis and data management using We serve our clients with state-of- the following tools: the-art clinical research facilities that offer adequate recreation, dining and Tools for Data Management and entertainment facilities for volunteers. Statistics Services: SAS Bioanalytical Services WinNonlin Kinetica We have developed and validated MedDRA methods according to US-FDA guide WHO Drug Reference List lines for various drugs using high technology and validated equipments. Strategically, the Kingdom of Thailand Our modern bio-analytical facility, lies at the heart of Southeast Asia, with operated by expert scientists, complies borders touching Laos, Myanmar, with the Good Laboratory Practice Malaysia and Cambodia, making it a (GLP) and ISO/IEC 17025 requirenatural gateway to Indochina. Thailand ments. Our hardware and software are is well-known as the Land of Smiles, 21CFR Part11 compliance. reflecting the nations friendliness and hospitality. These factors have helped Instruments us to influence and blend our company UPLC-MS/MS and staff into something unique and HPLC with UV-Visible, impressive for our clients in Thailand Fluorescence and Photo diode and will help us to forge similar rela array detectors tionships across all ASEAN countries. Deep freezer for sample storage Let Bio-Innova and Synchron take care (-40 C, -80 C) of your delicate and meaningful research study. We are your natural partner of choice in Thailand and Southeast Asia.

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SYNCHRON RESEARCH SERVICES PVT. LTD. The Chamber 3rd Floor, Sarkhej-Gandhinagar Highway, Bodakdev, Ahmedabad-380 054 INDIA Tel: +91 79 26853419 +91 79 26840427 +91 79 26840348 Fax: +91 79 26853415 www.synchronresearch.com SYNCHRON EUROPE Ms. Stephanie Burger-Prin Tel: +33.6.74.33.13.18

BIO-INNOVA AND SYNCHRON CO., LTD. 19/11-14 Soi Wattana, Sukhumvit 19 Road, Klongtoeynua, Wattana, Bangkok 10110 THAILAND Tel: +66 (0) 254-9008-9 Fax: +66 (0) 254-9007 www.bio-innova.com