For the past 6 years, SRL has been performing optimally, not only as a Clinical Reference Laboratory, but also as a Central Laboratory of repute for clinical studies - as a unique provider of clinical laboratory testing and essential support services in both domestic (India-specific) as well as global protocols of the highest order.

Specifically for the clinical research needs of the pharmaceutical industry, we have established a separate division - SRL Ranbaxy's Clinical Research Services - that offers services essential for all stages of clinical research, namely Phase I through Phase IV studies.

SRL's CAPABILITIES FOR FULFILLING THE ROLE OF AN IDEAL CENTRAL LABORATORY

· CAP and NABL accredited test menu comprising of assays in the areas of Routine Chemistry, Hematology, Microbiology, Mycobacteriology, Endocrinology, Molecular Biology, Cytogenetics, Flow Cytometry, Immunohistochemistry and Infectious Disease Serology.
·    Customized specimen collection and packaging material for clinical trial purposes, designed in accordance with the safety and quality control regulatory requirements for Intra City, inter city and international specimen transport.
· Customized documentation to be provided to investigators, including Investigator's Manual, test requisition forms, Customised Identification labels etc.
· Logistics capability to pick up specimens from multiple centers across the country and abroad by virtue of contracts with leading national and international courier agencies
· A state-of-the-art Laboratory Management System capable of recording and archiving patient data on a per patient basis for individual clinical trials; such data can be recovered for 15 years after completion after trial
· Storage facilities available for trial specimens at requisite temperatures for a minimum 2 years
· One point contact by way of a Clinical Research Coordinator appointed for each trial to facilitate and coordinate the smooth conduct of the study at site.
· Multiple reporting options for the ease and convenience of the investigator at site by way of hard copy courier, fax, telephonic result call out, email, and web-report
· Well-established & experienced R & D department to service new assay requirements of a trial
· IT and Quality systems well in place to preserve the confidentiality of data generated from the contracted Clinical Studies.

Synchron is a leading Contract Research Organisation in India providing broad range of clinical research services including bioavailability, bioequivalence and pharmacokinetic studies in compliance with GCP, GLP and other applicable guidelines and regulations. Synchron's Ahmedabad facility aims to provide research services to Pharmaceutical industries, encompassing a whole range of Clinical Trials, Product Registration, Statistical Analysis, Pharmacokinetics consultancy and Clinical Research Data Management.

Synchron has commenced its operations in Bangalore to provide clinical research services for phase II-IV   and Data management for clinical research.  The services would include Protocol Development, Feasibility Studies, Investigator
Identification, Independent Ethics committee Submission (site wise), Regulatory Affairs, Clinical Trial Coordination and Project Management, Data Management and Statistical Data Analysis and GCP training courses.

Synchron's Professionals have a totally scientific approach, are highly professional and committed with good knowledge and training in GCP/GLP.

Synchron functions with a set of detailed Standard Operating Procedures (SOP's) for all Phase I-IV clinical trials and Data management activities. Data management operations are completely validated as per the regulatory requirements.

VIMTA Labs Ltd. provides contract research services in the areas of clinical trials, bioequivalence (BE) studies, pre-clinical (animal) studies and central lab services. Established in 1984, VIMTA has an envious track record of providing contract research and testing services to several prestigious clients across the world, including three of world's 'Top Ten' generic drug development companies. With its headquarters and central lab located in Hyderabad, India, VIMTA offers significant benefits to its clients by the way of savings in research costs, and faster turnaround times due to quicker subject/patient recruitment and round-the-clock central lab services.

SERVICES OFFERED

VIMTA is a full service CRO (Contract Research Organization) offering the following services to drug development companies:

• Clinical trials (phase I to IV): project management; protocol preparation; adverse event reporting; data management and biostatistics; report preparation; central lab services - bioanalytical and pathology; IRB/ IEC services
• Bioavailability (BA) and Bioequivalence (BE) studies
• Pharmacodynamic and pharmacokinetic studies
• Pre-clinical (animal) studies - toxicology and efficacy

INFRASTRUCTURE

The Central facility of VIMTA at Hyderabad (India), comprising Clinical Pharmacological Units (CPUs) and clinical reference lab, is equipped with latest analytical instruments and computerized data management systems using LIMS and Nugenesis? SDMS). Well trained and highly motivated, the staff at VIMTA includes 15 doctors and 17 PhDs, and over 170 research scientists. Quality is the key driver of VIMTA's services. Over 200 SOPs and an independent Quality Assurance (QA) team ensure that the quality of services delivered to our clients is systems driven.

OUR CREDENTIALS

VIMTA has so far conducted over 600 animal studies, clinical trials and BA/BE studies involving around 150 drugs. Our study data is part of drug dossiers filed with various regulatory authorities in Asia-Pacific region, EU, Africa, US and Brazil. Our clinical research facility has been audited by several pharma MNCs and the regulatory authorities of Brazil (Anvisa), South Africa (MCC) and India (DCGI). US FDA has recently approved an ANDA filed by one of our clients based on our study data. VIMTA has been accredited to ISO 17025 by NABL, India. VIMTA staff have undergone external training on GCP and GLP.

INTRODUCTION:

Lotus is a private limited company incorporated as per the Indian Companies Act. Its head office is located in Bangalore, India.  Lotus commenced its operations in February 2001. The major activities of Lotus are as follows:

-    Bioequivalence Studies
-    Phase III Clinical Trials

In the last 3 years of its operations it has completed more than 300 bio studies. Phase III operations commenced recently with two ongoing projects which started in the month of June 2003.

CLINICAL:

The clinical facility of Lotus is spread in two locations.

Location 1:  
Total area of 10000 sq. ft.
Capacity of 72 beds
Screening Area
2 fully equipped ICU
Dining area for subjects
Recreation area for subjects
Documentation area
Quality assurance                     

Location 2:  
Total area of 7000 sq. ft.
Capacity of 52 beds
Screening Area
Fully equipped ICU
Dining area for subjects
Recreation area for subjects
Documentation area
Quality assurance

ANALYTICAL:
Operating in a 10000 sq.ft. area
State of art equipments like LCMSMS, HPLC etc
We have 3 LC-MSMS - One API 2000 & Two API 3000 of MDS Sciex                                                                                         

CENTRAL LAB:
We have our own Central Lab to take care of clinical laboratory investigations

CURRENT SCENARIO:

-          Approved by Drugs Controller General of India
-          Approved by ANVISA, Brazil
-          Inspected by French FDA and approved
-          Submitted studies for UK MHRA
-          Conducted pilot studies for US based companies
-          Certified as ISO 9001:2000 Company for Clinical & Pharmaceutical Research by the certifying body NQA
          Most of the major Indian pharma companies and multinational companies like Novartis and Sanofi are our clients today.
-          Conducted totally more than 300 studies till date.
-          Two Phase III trials have started and preparatory work for the third trial is on.
-          More than 80 Methods developed and validated.

TIE-UP:

Lotus is tied up with St. John's National Academy of Health Sciences, Bangalore for conducting Phase I trials. St. John's is a 1200 bed hospital covering most of the important branches of medicine starting from pediatrics, cardiology, oncology, obstetrics etc.

Lotus is constructing a 20000 sq. ft. building inside the 125 acre campus of St. John's for housing its Phase I facility. The building will be ready in June 2004.

Contact Details:

Clinical :                                               BioAnalytical :

No. 582, KCA Enclave                          No. 15, 80 ft. Road,
8^th Block, Koramangala                         S.T. Bed, 4^th Block, Koramangala,
BANGALORE - 560 095.                     BANGALORE - 560 095.
Tel: 91-80-5704175                               Tel  :   91 - 80 - 5633098
Fax: 91-80-5704176                              Fax :   91 - 80 - 5633101

Mr. Sudhir Pai .J, Managing Director
Mobile:  0-98454-83284
e-mail: sudhirpai@lotuslabs.com 

Dr. Saral Thangam, Vice President & Medical Advisor
Mobile : 0 - 98451 24304
e-mail : saralt@lotuslabs.com

Genesis Management Consultancy Services is a Mumbai based boutique financial advisory organization providing specialized services in pharmaceuticals and biotechnology. We offer a gamut of unique services to harness the maximum value to our clients by being flexible and through in depth research. Genesis is founded by a team of well-experienced professionals hand picked from investment banks & industry aiming to provide financial advisory services with focus on pharmaceutical and biotech sector. Our professionals with their proficiency in each sector are able to efficiently tackle high-end tasks. Besides our in-house competence, we have a team of specialists from the industry, academia, and investment banks both domestic and global who can impart expertise all through the project.

Genesis's clients include large to mid-sized pharmaceutical, biotechnology, CROs, life sciences technology licensing and fine chemical companies. We offer a host of financial advisory services to the pharmaceutical and biotech companies, which include:

• Mergers and acquisitions, Techno-commercial Due diligence
• Strategic planning for acquisitions and divestures
• Securing financing for acquisitions and expansion as well as developing and negotiating joint venture
• Representing clients seeking strategic partners and alliances
• Advising clients on entry strategies and global transactions
• Technology transfers
• Pharmaceutical reports

We do hand holding from concept to commissioning for ventures in biotech, Genesis has a developed a keen interest in CRO industry in India backed by the expertise of Technomark Consulting Services, UK. Genesis has built an exclusive database of Indian CROs and is in the process of expanding it to the Asia-Pacific. Genesis is also taking up the initiative to form the Indian CRO Association.

Genesis has a strategic alliance with Technomark Consulting Services, UK to represent them exclusively for India. Technomark Consulting is an innovative, specialist consultancy group, in pharmaceutical and biotechnology having a core focus on CROs. We bring in the entire range of services and expertise of Technomark Consulting Services, UK to the Indian sub-continent.

For more details visit  http://www.genesismcs.com