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www.synapselabs.

com

re search life Biometrics

Bioequivalence

Clinical research Data management


True
True to its name Synapse gives you timely services
that help you reach your goal efficiently.
We at synapse understand the importance of speed, quality and
reliability hence we have invested heavily for security of
data, and we work round the clock on advanced
instruments for guaranteed, fast and quality
results.

In today’s capital intensive & highly competitive market one need to


have a partner who can understand & deliver the client needs at a
speed of an electrical impulse without any loss of information like
our nervous system.

In our nervous system no neurons run directly from the periphery


to the brain and need help of intermediate neural cells
interconnection called “SYNAPSE”. Synapse has a special role to
transfer electric activity(information) from one neuron to another
and helps in information processing.

In a same way at “Synapse Labs” we sense your eagerness and need for drug
development and deliver results at a speed of electrical impulse in a most
efficient way without compromising quality at a comparative cost.

All it comes together via interconnected network of dedicate team focused


on managing your projects.

“Synapse lab” is based in PUNE a growing IT and Biotech


centre of India. Very near to Mumbai, Asia's fastest growing
city, with world class infrastructure with two independent
clinical units with separate phlebotomy, dining, recreation
and investigation area.
Clinical Research
Services offered by us includes
• Bioavailability / Bioequivalence Studies • Phase II-IV Clinical Studies
• Clinical Data Management • Biometrics & Report Writing

Bioavailability/Bioequivalence Studies
We have expertise in conducting following type of BA/BE Studies

• Fasting Studies
• Food Effect Studies
• Drug-Drug Interaction Studies
• Multiple Dose and Steady State Studies
• Dose Linearity Studies

Clinical Data Management


For consistent, accurate, reliable clinical trial output as per
regulatory requirements, our competent team performs
following functions

• Setting Clinical Data Management Process


• Clinical Data Processing
• Medical Coding
• Quality Control

Phase II-IV Clinical Studies


Our experienced project management team can support you in your clinical
development program

• Regulatory Consulting
• Investigator Site Selection/ Site Feasibility Studies
• Clinical Trial Operations
• Clinical Trial Supplies Management
• Site Management
Biometrics
Experienced medical writers & statisticians are involved in each part of study to
device study design, generate accurate & compliant study reports.

• Preparation of Statistical Analysis Plan


• Randomization & Sample size calculation
• SAS Programming & Statistical Analysis
• Report writing as per Regulatory Requirement

Synapse – Junction for your Clinical need


Synapse support its customers with basket of services under one
roof ranging from various types of clinical studies for dossier
Submission for Generics as well as NCE products to USFDA,
MHRA, MCC, WHO or applicable regulatory agencies.

“Connect to Grow”
Bring accuracy, speed & success together

Majestic Plaza, S. No. 21/5,Nr. Nyati Empire,


Kharadi-Mundhwa Bypass,Kharadi, Pune-411 014.
Ph. : (+91) 20-27014555, Mob. : +91- 9960144544, Fax : (+91) 20-27013444
E-mail: ravindrabhavsar@synapselabs.com - www.synapselabs.com

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