Clinical research and medical care in health care system
The focus of the clinical research is to create knowledge and provide clinical evidence for improving the patient’s health outcomes in medical practice. #WorkSure offers #clinicalresearch solutions for #pharmaceutical companies.
Pre-clinical and
Clinical Trials are must for every drug that we use today. It has gone through
rigorous multi-step process of testing and evaluation to explore everything
about the drug. It takes a lot of time, effort and resources to know about the
risks and benefits of a particular drug before it reaches a patient. The drug
development process comprises of two pivotal components namely preclinical
studies and clinical trials. Before a drug is tested in human subjects (or
clinical trials), it is important to know about the safety, effectiveness and
optimal use on people. For this, preclinical studies are conducted in both in
vitro and in vivo models that provides information and evidence
about the candidate drug’s biological effect. The testing of a drug in
pre-clinical studies is done in non-human subjects that can be animal/model
organisms or cell lines. It covers information about the pharmacodynamics and pharmacokinetics
of the novel agent including organ system toxicity, besides potential hazards
of carcinogenicity, mutagenicity, and teratogenicity. The preclinical findings
form the basis of clinical research and allow researchers to estimate a
safe starting dose for human testing. Majority of the drugs that undergo
laboratory or animal testing never even make it to the next step of drug
development, i.e., clinical trials.
Clinical trial is the
systemic study of new drug(s) in human subject(s) to generate details for
verifying clinical pharmacological effects and adverse effects with an
objective of determining safety and efficacy of the new drug. Drug studies in
human subjects are conducted only after the primary data of the novel drug
gathered from preclinical studies is reviewed by a local institutional review
board (IRB) and Drugs Controller General of India (DCGI) grants permission for
the same. At this stage, the DCGI decides whether it is reasonably safe for the
pharmaceutical company to further conduct testing in humans. The IRB is
responsible for the approval of the clinical trial protocols and consists a
team of physicians, statisticians and researchers to ensure that the clinical
trial is ethical, protects patients’ rights and is appropriate to answer all
the queries asked from both scientific and statistical point of view. Clinical
trials involve healthy human volunteers or patients and is used to learn if the
new treatment is more effective and/or has acceptable level of adverse effects
as compared to the standard treatment. Traditionally, clinical trials are
divided into four stages and the number of subjects participating increases in
each subsequent trial phases.
Phase-0 or microdosing
study is an exploratory investigational new drug study that involves a small
number of candidates, around 10-15 people. It does not give any drug safety or
efficacy data, but helps decide which pharmacokinetic parameters will be the
best to take forward in the next phases. Also, this phase ensures the early
bioavailability, half-life and pharmacodynamics of drug to minimize the losses
if the drug fails in later stages. Usually, drugs undergoing phase-0 trials
often skip phase I. The next phase I is the dose escalation, tolerability
studies that has a primary goal of dose ranging to find the best dose with
fewest side effects for the novel drug. This phase involves 20-100 healthy
volunteers and establish maximum tolerated dose, pharmacodynamics and
pharmacokinetics. To evaluate the effectiveness of the drug for a particular
indication(s) in patients and to determine common short term side effects and
risks, phase II or therapeutic exploratory studies are conducted. It includes
100-300 participants with a particular disease and lasts for several months to
2 years. In this phase, the drug is not presumed to have any therapeutic effect
whatsoever and required to be proved all over in phase II. Phase II are
therapeutic confirmatory trials, involving large population of 1000-2000
individuals to confirm Phase II findings This phase is essential as it provides
an adequate basis for marketing approval. This phase is conducted before the
new drug is approved for its use in the general public. Once the drug is
approved, post approval research and monitoring or Phase IV are conducted to
closely monitor long term safety and efficacy of the drug marketed, while
comparing with already approved drugs. Additional Phase IV is sometimes
conducted that involves research on the collected data instead of dosing or
monitoring.
Therefore, preclinical
trials explore the potentially hazardous drug in nonhuman animals and provides
the first substantial, biological data that forms the foundation for clinical
studies. Preclinical phase not only protects human volunteers for toxic
exposure but also provides researcher an opportunity to explore detailed
safety/toxicology profile of the novel drug. Further, clinical trials lead the
deserving candidate drugs to the therapeutics and extrapolate preclinical
safety and efficacy findings to human system where the drug is finally used.
WorkSure® provides an integrated customized technology driven, user friendly interface ensuring efficient delivery. Our use of technology for gratification of the clinical trial process, adherence to strict compliance standards
WorkSure® provides expert consultancy services with
competent strategy and content for medical communications to the pharmaceutical
companies facilitating them to involve with their customers about their current
discoveries, interventions or therapies. It helps to devise risk management strategy (REMS/RMPs) for a pharmaceutical company.
A survey is a powerful tool that can help to collect insights about products, research, employees, users, markets and much more. Sci-précis is a survey application that can obtain access to valuable data (including collaboration with third parties, academics, providers and payers) and then unique granular insights will be developed after merging advanced analytics with visualization and creative technologies. It provides a multi-tasking, user-friendly, secure and flexible platform that significantly reduces time and effort for executing any kind, type or size of survey. This app provides many options of pre-created potential templates that reduce the time and effort for creating and customization of required templates. This app can be used to understand consumer experiences and behaviours as well as to reach wider population even in remote areas.
One of the most effective ways to gather all the required research related information is to create a user friendly and informative template that helps in engaging more participants. One can customize question as per your research requirement i.e. question can be displayed on a single page or one at a time; filtering respondents that fit as per your protocol; branching questions as per respondent’s selection of answer. This app will have many features such as tracing of product feedback, conducting market research, obtaining scientific view points on products, measuring KOL perception, data analytics and much more. The aim is to provide the best survey customization platform to our customer’s and continue to thrive. Smart thinking means, sustainability of customers and accomplishment of best quality surveys.
•Surveys related to general business, community, demographics, industries, non-profit organization, political associations and much more
•Online market research surveys to understand customer’s need, measure product’s awareness, improve customer retention, perform economic evaluation and much more
•Manage Q/A round, event related activities, collection of opinion over a topic and even obtaining consensus for specialized DELPHI studies
•Understanding situation of ongoing classes and obtaining timely feedbacks about the lesson in an educational institution
•User-friendly and creative templates prepared to obtain valuable feedbacks from customers
•Storing/sorting/reviewing job applicant’s online, interviewer’s/employee review, employee’s satisfaction surveys and exit interviews in an human resource department of any institution or company
•Customization of question as per the research requirement i.e. question can be displayed on a single page or one at a time; filtering respondents that fit as per your protocol; branching questions as per respondent’s selection of answer
Benefits of Sci-précis
•Multitasking user platform on mobile, tablet and laptop
•Feedbacks or data can be analyzed, filtered or reviewed from where ever you travel
•Use push notifications to receive real time-update
•Provides many potential user-friendly templates pre-created by experts which will reduce time and effort
•Share your draft to obtain opinion from stakeholder’s/expert’s/colleagues before survey is sent to the public
•Highly secure platform will keep your data safe
•Data can only be accessed through One-time Password which will save you from remembering passwords
•Pre-generated links will help to directly share the survey on potential social media platforms
Corporate Information Management System consist of information that can be efficiently shared between two or more organizations. Corporate systems include any system that is used by or is of benefit to more than one organization to create, update, or delete corporate data. Corporate Information Management System deployment assists in efficient use of all resources to achieve higher profits by enhancing management solutions. Nowadays both big and medium-sized companies are investing in generation and implementation of a Corporate Information Management System. With the development of market economy and the intensification of market competition, corporations require not only quick business process reengineering and continuous business process changing, but also faster information system reengineering correspondingly. This software is based on state-of-the-art technology that also guide in integrating the conventional subsystems already used in the company into a Corporate Information Management System. Thus, in modern conditions business running constant changes implementation is a necessary element of survival and competitiveness increase.
Survey apps are the platform used
by many companies of all sizes to build, design and manage online or electronic
surveys. Unlike manual survey, these apps optimize data collection, reduce
costs and require fewer labours. These apps is used by companies to understand
consumer experiences and behaviours as well as to reach wider population even
in remote areas. By 2021, the global market of online survey applications is
expected to reach up to $6.92 billion (Source: Technavio).
Use of survey apps in healthcare community
Hospitals, small clinics or
universities also conduct surveys as an aspect of their medical research. The
survey app provides effortless collection and analysis of data obtained from
basic research, epidemiological studies, or clinical trials. The healthcare
community is continuously involved in conducting quality medical research to
improve lives of people all around the world. The survey apps often proves to
be the best medium to gather data, collect health statistics and understand
patient outcomes
What are the benefits of using the survey apps?
Makes the management of medical survey easy: Some researchers are
very specific and thus requires customization. However most of the protocol
requires a general survey template for collecting the responses.This app provides many options of potential
templates that are created by experts of the field. This reduces the time and
effort for creating and customization of required templates.
Improving business operation: In current scenario, most of the
businesses are data driven. Initially companies use to collect these data
manually through interviews and paper questionnaires which was a tedious and
costly process. On the other hand survey apps are user friendly and thus
attract more responses. Companies can collect market, user and employees
insights. The survey software can be customized and modified as per requirement
at any stage. These apps also provide various filters such as demographic data,
specific answers, time period, etc., which can help a company to focus on
particular criteria.
Evaluate scope of healthcare industry: A healthcare provider or
researcher can use this app to explore potential barriers or benefits of
healthcare access among special groups such as senior citizens, differently
abled or poor families. It can guide a pharmaceutical company to optimize its
product reach to every possible location around the world.
Healthcare feedback: Offline survey apps can effectively conduct
patient’s surveys for healthcare providers and pharmaceutical companies for
determining factors that might improve or exacerbate the consumer’s response. The
results obtained through these surveys can provide useful insights and future
perspectives. Survey’s can be used to schedule consultation and it delivers a
hastel-free consumer experience.
Maintain confidentiality: The app also keep the data private and
secure. Confidentiality of healthcare information acquired either for market or
medical research is a very important aspect. This app assures the privacy of
sensitive data to inspire the use of this platform confidently.
Promotes innovations in biotechnology sector: Over the years the
field of biotechnology has spread its branches in industry, pharmacy/medical,
environment/marine and agricultural/food. Biotechnology plays a role of major
contributor in commercializing research. Many biotech-industries conduct
surveys to understand the scope of their product among general population. The
results from the surveys also help in deciding the intensity of advertisement
that will be required to promote the product
WorkSure SciPrecis provide the real time
insights for the drugs (Pharma, Biotech) or medical devices, conducts
epidemiological surveys, market research and perception studies.
WorkSure team of doctors and IT professionals
have developed an application, named Sci-précis, to produce the real time
insights survey platform for the pharmaceutical drugs or medical devices. This app will have
many features such as tracing of product (drug/medical device) feedback,
conducting market research, obtaining scientific view points on drugs/devices, measuring
KOL perception and data analytics.A real-time experience tracking method has
been long sought by many companies to capture products performance immediately,
reduce the loss and minimize bias. We believe a product perception in real time
can gain insights that can be quickly interpreted. To know more mail us at info@worksure.org
