Vision and Mission

 VISION :

To be a preferred and globally respected research partner for Regulators, Pharmaceutical, Biotech, Medical Devices and Healthcare IT companies

 

MISSION :

To achieve our vision by conducting our duties in highly ethical environment and providing our services with honesty, quality & compliance to regulators, our clients, stake holders and employees.

We also advocate the clinicians, researchers and patients in best possible ethical ways to expedite the development of new medicines and/or technologies that alleviate suffering of the patients.

 

People

/>ClinSync has brought together under a common umbrella people with a depth and breadth of vision and thinking and with interests ranging from preclinical up to late stage trials aiding research into NCEs. While each of our people has a unique set of interests and needs, we all bring a strong result orientation, sense of urgency and ambition to make a positive difference to our client's businesses.

 

Other common traits define Team ClinSync

  • Inquisitive mindset
  • Can-do attitude and eagerness to achieve
  • Eagerness to develop oneself and learn
  • Willingness to work for the team and the company
  • Interest in international exposure.
  • Customer serving attitude
  • High personal ethical standards
  • Passion for intelligence & advisory

Key Achievements

  • March 2015 USFDA Inspected our Facility
  • Dec 2014 Received Bio-analytical facility approval from DCGI
  • June 2014 EMEA Inspection completed
  • June 2014 Netherlands Medical Evaluation Board
  • June 2014 French National Agency for Medicines and Health Products Safety- Combined inspection
  • April 2013 Clinical Operations Group extended Investigator network to South East Asia
  • April 2013 ISO 9001:2008 Quality System Accreditation
  • April 2013- USA  Marketing Operations
  • Dec 2012 Completed 25 studies in 6 months of Clinical Operations
  • Expanded Investigator Network in Ethiopia
  • Flagged pre-clinical (Regulatory Planning), DMPK and Statistics Services to clients
  • May 2012 First BA/BE study Conduct
  • April 2012 First Indian CRO to be approved as BE Center and also as hospital to conduct PK/PD, Patient based PK and Phase studies
  • March 2012 BE Center Inspected by DCGI

Corporate Overview


Corporate Overview:

ClinSync is the realization of a long-cherished dream of a team of enterprising and accomplished medical doctors who made their mark in their respective therapeutic areas. They share a deep sense of commitment to improve the quality of life of suffering patients, to provide access to medicines and technology, to focus on diseases burden to India (Tuberculosis, HIV, Malaria, Filarirasis), oversee the conduct of high-quality research, clinical trials and enhance the ethical conduct of clinical research in India.The CRO nurtures a dedicated scientific team to provide seemless support to pharmaceutical, biotechnology, academic institutions from translational research to Marketing Authorisation Approval.

ClinSync’s team consists of highly skilled and experienced principal investigators, pharmaceutical scientists, basic scientists, quality and regulatory associates. Together we design and implement clinical trials with meticulous attention to sponsor protocol and scrupulously carry out the assigned treatment / therapy plans so that the clients’ objectives are always achieved leaving no scope for any later stage clinical trials mishaps.

Business Overview:

"Clinsync offers Breadth and depth, plus seamless integrated service study planning to regulatory submission within the context of our six core competencies"

  • Clinsync is a service provider to the pharmaceutical, biotechnology and generic industries, with its head quarters at Hyderabad, India
  • Six Core Competencies
  • - Oncology and Special Population
  • - Early Stage Clinical Development
  • - Bioanalytical
  • - Late Stage Clinical Development
  • - DMPK/Toxicology/Medical Writing/ Biostatistics
  • - Biosimilars
  • Strategically located sites (100+ employees) in India, Singapore, Ethiopa and US:
  • - Clinsync India (Hyderabad, India)
  • - Clinsync Singapore (Singapore)
  • - Clinsync USA (Simsbury, USA)
  • - Clinsync Ethiopia (Addis Ababa, Hospital)

 

‘ClinSync offers breadth and depth, plus seamless integrated service study planning to regulatory

submission within the context of our six core competencies’

       ClinSync  is a service provider to the pharmaceutical, biotechnology and generic industries, with its Head Quarters at Hyderabad, India

       Six Core Competencies:

      Oncology and Special Population

      Early Stage Clinical Development

      Bioanalytical

      Late Stage Clinical Development

      DMPK/Toxicology/ Medical Writing/ Biostatistics

      Biosimilars

       Strategically located sites (100+ employees) in India, Singapore, Ethiopia and US:

      ClinSync India (Hyderabad, India)

      ClinSync Singapore (Singapore)

      ClinSync USA (Simsbury, USA)

 

      ClinSync Ethiopia (Addis Ababa, Ethiopia)

Business Strategy

Innovation is the specific instrument of entrepreneurship, the act that endows resources with a new capacity to create wealth – Peter F. Drucker.

 At ClinSync, providing innovative solutions to the clients is the driving factor for our business positioning and success. These solutions may vary from identifying appropriate answers to the research questions to catalyzing the development of molecules. We strongly believe that innovations are all about the people we have. We have the best in-house experts who strive for the best scientific solutions and applications by integrating technology and IT tools. We believe an environment of trust and mutual respect is a key factor to ensure consistent and long-term growth and prosperity.

 Our business strategy focuses on providing long term solutions to our patients, clients, physicians and regulators.

We are committed to conducting researches for the betterment of mankind and providing high quality, regulatory compliant services.

 Investigator Delivery Model

In the present scenario of clinical trials much time is spent on finding the apt patient for conducting trials. We at ClinSync have developed ‘Investigator Delivery Model’- a copy righted application, it identifies the geographic location of the patients and connects them to established sites/ investigators as well as new investigators who can care for them and help them participate in clinical trials. This model ensures that the physician spends more time caring for the patient than searching for a subject. This model also ensures the enrollment of agreed number of patients with least possible sites thereby saving cost and time.

 Current process of research conduct:

 Sponsor ------------ > CRO ------------ > site selection ------------ > site initiation ------------ > identifying patients

 IDM process:

 Sponsor ------------ > CRO ------------ > identifying patients ------------ > site selection ------------ > site initiation

  • Web based application www.clinsyncapps.com TM
  • ClinSync acts as a hub and currently has 18 satellite centers across India
  • Around 2,80,000 integrated patient database across 65 therapeutic indications from 18 centers
  • Dynamic database- its designed is based on most common and critical inclusion and exclusion criteria.
  • Geographically maps and identifies the patient pocket, helps ClinSync to identify best sites.

"Identifies the geographic location of the patients and connects them to established sites/investigators as well as new investigators who can care for them and help them participate in clinical trials".

 With this application, ClinSync has the advantage of better recruitment as:

    • ‘The incidence pockets’ are identified and mapped across the subcontinent. It helps to focus equivalence studies in high incidence regions, where the patho-physiology of disease will be uniform and the variability will be minimized. Conversely, it also helps to choose diverse population for Phase III designs.
    • Seasonal incidence trends [like dengue], variability of severity of diseases [like asthma] will form an excellent platform for sponsors to design most scientific protocols as well as time projections.
    • With uniquely designed filters the data could be readily interpreted, which are in line with most commonly used eligibility criteria.

 Case study in Innovations

  • Sponsor requested for a therapeutic molecule in colorectal and breast cancer
  • Proposed 6-10 centers 8 months recruitment period for 120 subjects 2 way cross over or 64 subjects 3 way
  • ClinSync had the following comments
  • S.ALKP levels if raises beyond 1.5 times C Max varies by 14%
  • A 50% decrease in creatinine was associated with a 53% increase in its AUC and a 41% increases in its Cmax
  • A 30% increase in body surface was associated with a 24% increase in the volume of distribution of FBAL and a 19% decrease in its Cmax
  • Based on these the protocol was suggested to get amended for eligibility criteria to restrict subjects with
  • <1.5 S.ALK P (which was earlier 2.5 times, which lead to increased variability in some)
  • BSA of <1.85 (which was not defined earlier)
  • Creatinine clearance of >50% (previously S.Creatinine of<1.5 times)
  • Allowing the study to complete in 4 centers in 8 weeks in 52 subjects saving cost and time
  • More importantly
  • The data is more scientific
  • Lesser variability compared to other published literature /Trials
  • The major challenge(clinical) of 3 period was overcome

To know more about our IDM, please contact us  This email address is being protected from spambots. You need JavaScript enabled to view it.

 Patient focused Research

 Necessity is the mother of invention – Plato

 We believe that the bedside of a patient stimulates brilliant ideas. With 18 practicing therapeutic experts on board and wide connectivity with patient networks/ groups, it will help us to:

  • identify patient need, develop research questions, translate them to research idea and prepare the appropriate business models to address the need.
  • Provide wide expert inputs to end points, study design, biomarkers, imaging and other scientific aspects of trial. This ensures balancing scientific integrity with operational feasibility of a protocol, to conduct a study minimizing protocol amendments, regulatory queries, cost and time.
  • identify challenges in current prescription practices
  • challenge non scientific prescription practices and invent new prescription practices

 To know more about how our strategy helps in expediting clinical development of your molecules, please contact us  This email address is being protected from spambots. You need JavaScript enabled to view it.

 We desire to synchronize practicing physician’s ideas with basic research scientist’s work. Our physicians are driving various research programs in following areas:

  • Transient hyperammonemia of the New born (THAN)
  • Cancer stem cell research
  • Biomarkers and radiological markers in oncology, immune and infectious disease.

 Our approach in country customized research helps in bridging gap between the researches conducted in the western world and Sub Continent and focuses on research needs in India. Our Public Health and Health Economics group primarily works on tropical and neglected diseases, which are a health and economic burden in India. PHHE group collaborates with various bodies and organizations like Indian Association of Public Health, Indian association of social and preventive medicine, various NGOs for the new research and development in following areas:

  • HIV/ AIDS
  • Tuberculosis
  • Malaria
  • Nematode infections
  • Kala-azar
  • Leishmaniasis