Clinical Research

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Clinical Research

Pharma Instinct Pvt. Ltd. provide consultation for all aspects of clinical research, ranging from trial designing, protocol development, and project management to data analysis and interpretation along with medical writing services.

We cater to for all phases of clinical trials for Ayush products, food products herbal products, herbal extracts, as per ICH- GCP. We provide cost effective solutions to our business partners for fast completion of clinical trials. Pharmacologists, medical specialists and bio-statisticians, provide their inputs for trial design, protocol development, analysis and preparation of all other required documents. At various stages of R & D interaction with medical specialists and pharmacologists is of great significance and can add value to the research products

For startups, small and mid size pharma as well as biotech companies, it is all the more important to keep medical specialist on their advisory panel. We associate medical experts, scientists and pharma as well as biotech industry together for the drug development process

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Clinical Trials

Pharma Instinct provides consultation for all aspects of Clinical research, ranging from trial designing, Protocol development and Project management to Data analysis and interpretation, along with Medical writing services.

We cater to for all phases of clinical trials i.e. Phase I to IV as per ICH- GCP. We provide cost-effective solutions to our business partners for fast completion of clinical trials. Pharmacologists, Medical Specialists and Bio-statisticians provide their inputs for Trial Design, Protocol Development, Analysis and Preparation of all other required documents. At various stages of R & D, interaction with medical specialists and pharmacologists is of great significance and can add value to the research products.

For startups, small and mi1d-sized pharma as well as biotech companies, it is all the more important to keep medical specialist on their advisory panel. We associate medical experts, scientists and Pharma industry as well as biotech industry together for the drug development process.

Some of the services of clinical trials provided by us include:

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Therapeutic areas of our focus are

Autism

BPH

CIT

Cognitive Health

Dementia

Diabetes

Dyspepsia

Early Cardiovascular Disease

Erectile Dysfunction

Osteoarthritis

Osteoporosis

PCOD

Pneumonia

Prediabetes

Testosterone Booster

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Medical Writing

Pharma Instinct has a team of experienced medical writers to provide high-quality clinical study documents (including CTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final study report preparation, our medical writers collaborate with biostatisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development. Every document goes through a rigorous internal quality assurance process, ensuring high-quality deliverables on time.

We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service. Our services mean all facets of a trial are covered by the one contract, which makes working with us simple and streamlined.


Our medical writers help you in the preparation of the following:

  • Clinical study protocol
  • CRF designing
  • eCRF
  • Informed consent forms
  • Investigator brochure
  • Log books
  • Study assessment questionnaire
  • Patient diaries
  • Clinical study reports (From Phase I – IV)
  • Abstract & manuscript for the publication of a clinical study in high-impact journals
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Data Management

The integrity of clinical data is of supreme importance to a successful project. Pharma Instinct ensures this integrity by strict adherence to established Standard Operating Procedures throughout every stage of a project.

Pharma Instinct works closely with clients to determine specific clinical technology requirements and then customises services to meet each client's unique clinical data storage and processing needs.

Our high-quality system and cost-effective solutions help to ensure successful management & delivery of clinical trial data. Pharma Instinct has extensive data management experience for Phase I-IV clinical trials.


Clinical trial data management services of Pharma Instinct include:

  • CRF designing
  • eCRF designing
  • Standard operating procedures (SOP) development
  • Data processing – including multiple entry of patient data (CRF, ICF, log books & test reports)
  • Confidentiality of patient data
  • Confidentiality of randomisation data
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Statistical Analysis

Pharma Instinct delivers accurate, high-quality and timely bio-statistical services including statistical planning, analysis and reporting.

We understand that high-quality statistical data is essential to achieve your research goals; thus, our team of experienced statisticians help our clients in developing the best research designs and models. Our team strives for accurate results and data analysis. They also make sure that our clients, those who know statistics and those who do not know statistical analysis, understand the importance of the techniques used and how the results can be correctly interpreted. Our team is fully skilled to use any statistical software.

We do Clinical Trial Data Analysis, Thesis Work Data Analysis, Research Design & Hypothesis establishment. Analysed data is presented in high-quality, professionally Designed Graphs & Tables. Each analysis undergoes a quality assurance check before its release to the client.

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Quality Assurance

Pharma Instinct always believes in “Quality is never an accident; it is always the result of intelligent effort”.

Pharma Instinct continually monitors and evaluates its own activities and improves all drug development processes. The team of Pharma Instinct divides the tasks of the project and multiplies the success. This success is achieved by well-planned quality assurance strategies.


These strategies include::

  • Adherence to Good Clinical Practices (GCP)
  • Development of Standard Operating Procedures
  • Quality maintenance of clinical research documents (involving every document of preclinical & clinical study)
  • Periodic monitoring
  • Internal Audits
Faq’s

Answers to Your Most
Frequently Asked Questions

Clinical Research is a systematic study for new drugs/products in human subjects to determine safety and efficacy of the new drugs/products.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

A volunteer subject with no known significant health problems who participates in research to test a new drug, device, or intervention is known as a "healthy volunteer" or "Clinical Research Volunteer." The clinical research volunteer may be a member of the community, an investigator or other employee, or family members of a patient volunteer. Research procedures with these volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Clinical research volunteers have always played a vital role in medical research.

Placebo is a harmless, inactive substance made to look like the real medicine used in the clinical trial. Placebo allows the investigators to learn whether the medicine being given works better or not than the ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, it is always be informed in the consent form given to the patient before the agreement to take part in the study.

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented bymeans of a written, signed and dated informed consent form.

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

ICH- GCP defines monitoring as the act of overseeing the conduct of a clinical trial, that is, ensuring that the trial is conducted according to protocol, GCP, SOP and regulatory requirements.

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6)

The health of millions has been improved because of advances in science and technology and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at the Clinical Center cannot be accomplished.

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