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
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
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
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
- Nematode infections