Bioanalytical Services

Brief Global Overview

ClinSync Bioanalytical facility is aimed to provide high quality, cost-effective sourcing solution for the analysis of PK and PD samples coming from preclinical and clinical studies conducted in entire Globe’

       State of Art set up with independent access-controlled Deep freezer area, Balancing room (Sartorius), sample processing area and instrumentation area.

       Small molecules LC/MS/MS – using mass spectrometric techniques

                > 2 Triple Quadrupoles Mass Spec (2 ABSciex API 4000)

        Have capacity to handle approx 3000-4000 samples per month

       Large Molecules - using ligand binding assay techniques (through partner channel)

       Initiated operations in Dec 2014

       Completed the MD and MV of Niverapine and MD of Pramipexole (MV expected to be ready by Feb 05)

       Rapid assay development, validation, sample analysis

       Supporting a full range of development from Preclinical to Late Stage Clinical programs

       Central Lab Services for clinical PK studies: Sample Logistics / Sample Repository / Preparation and Distribution of Sampling Kits

       Core team of bio-analytical personnel having experience of handling critical molecules such as ethinyl estradiol, gestidine and prostidine

       Complete back up for the LC/MS to aid any system break downs

       SOPs and Bio-analytical method validation (including Incurred Sample Re-analysis) in compliance to US-FDA and EMEA guidance

 Brief Global Overview

       Developing and Validating Bio-analytical Methods involving

                > Drug and Metabolite from same Sample

                > Multiple Analytes in same Sample

                > Highly Sensitive Methods with detection as low as pg/mL

                > Can quantify even with low sample volume (nearly 0.1 mL)

                > Extraction procedures include protein precipitation, liquid-liquid extraction, solid phase             extraction.

       Use of 17.2 Mega ohm water for all analytical processing and chromatographical methods.

       Collaborations with logistical vendors across the globe like World Courier and PDP to successfully handle sample receipt from various locations within India, across US, Europe and China to support multi-national and multi-centric trials.

       Can handle different matrices like Plasma, Blood, Brain homogenates, Cerebro Spinal Fluid, Urine, Feces, any hard tissue (colon, spleen etc), Microsomes, Bile, Isolated Brain Regions, Assay Buffers

       PK Study with 1500 samples

> Preliminary Data within 2 weeks from sample receipt (for discovery side)

> Audited Data within 2 weeks of last sample analysis

> 48 hour turnaround, if needed for dose range/escalation study

 Small Molecule LC-MS/MS

       Bioanalytical Method Development & Validation

       Sample Analysis for different evaluation purposes:

      Pharmacokinetic (PK) screening

      Toxicokinetic (TK) studies

      Clinical PK/Bioavailability studies

      Bioequivalency studies

      Therapeutic drug monitoring studies

      Biomarker studies

      Drug-drug interaction studies

       Sample Analysis of different compound structures:

      Oligonucleotides Analysis

      Peptide Analysis

       Sample Analysis in different biological matrices:

      Dried Blood Spots

      Tissues

 

Late Stage Clinical Development

ClinSync has developed expertise and capability in the field of technically matured drug metabolism and pharmacokinetic (DMPK) services. PK/PD modeling and simulation has of late substantially influenced the design of early clinical studies.

The company’s biostatisticians and pharmacokinetics experts evaluate data by using the latest techniques. Through their world-class skills they conduct in vivo pharmacokinetic evaluations and analyses.

ClinSync’s clients and collaborators get access to its wide range of capabilities in conducting advanced PK/PD experiments covering areas such as toxicology and pharmacology. Through its comprehensive drug metabolism and pharmacokinetics cost-effective services the company helps its clients meet their objectives.

Translational medicine research

ClinSync has a long-term commitment to become a significant contributor in the development drug discovery by effectively maintaining a world-class translational structure. The company provides translational research services in clinical trials in keeping with the fast-changing advancements in basic sciences.

The efforts of the company have paved the way for several opportunities and new therapeutic concepts for drug discovery. Its therapeutic categories include oncology, dermatology, immunology, nephrology, endocrinology, gastroenterology, cardiovascular diseases and infectious diseases.

ClinSync has a well-knit team of researchers, scientists and physicians who together enable effective inter-disciplinary findings for improved healthcare through constant innovation. Its translational research focuses mainly on cancer drug development.

Oncology and Special Population services

ONCOLOGY AND SPECIAL POPULATIONS

Large pharmaceutical and biotech companies prefer to have a specialty oncology CRO available to handle specific Oncology based challenges during their product development, whether it’s to support their in-house team or bring specific expertise to the table, or provide a second set of eyes on the lead CRO’s work, ClinSync can provide these services a la carte or under a master services agreement as they have highly qualified medical and scientific experts on board to meet your needs in Oncology and Special population studies that are highly complex to execute”

ClinSync Investigators and staff's experience is our biggest asset with a team of senior Medical Experts and  scientists that all have on average of more than 15 years of pharmaceutical and biotech drug discovery and development experience. Majority of them were KOLs in various pharma / biotech advisory boards or development teams with a cumulative experience of more than 10 INDs/NDA submissions.

Clinsync’s experts are committed for Scientific Integrity and Quality, strong program Development and Consulting, Fast track regulatory approvals, Fast recruitment through Investigator Network, and Satellite investigator sites, expertise in handling Clinical PK studies and Seamless Project Management.

 

End to End Services Includes:

Oncology

HIV/ TB/ Malaria/ Hepatitis and other infectious conditions

Post menopausal women

Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies

Hepatic Impairment

Renal Impairment (at partner Kidney Center)

Hypogonadal studies

Contraceptive studies

Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes 

EARLY STAGE CLINICAL DEVELOPMENT

ClinSync offers a broad range of early development services, including drug discovery and development, Phase I clinical trial services, and nonclinical consulting, helping clients increase efficiencies and accelerate the drug discovery and development process. Our scientific expertise and experience as well as wide range of equipment and services enable us to meet clients’ drug discovery needs.

ClinSync has already proved itself to be one of the best partners in Asia to outsource clinical research by creating a highly dependable clinical research and development services from phase I through Phase IV. Today the company has built a reputation for assisting its clients in designing, developing and implementing a wide variety of clinical trial solutions. It also help clients by providing access to excellent facilities that include clinical pharmacology units and trial management centers.