International Congress on Advances in Clinical Research and Trials

Pre Clinical Research

It is a period of research that starts before clinical primers (testing in individuals) and during which believability, iterative testing and prescription security data are assembled. Preceding testing a medicine in people, examiners must check whether it can cause real hurt, also called harmful quality. The two sorts of preclinical research are: 
•    In vitro 
•    In vivo 
Preclinical studies are not gigantic. Regardless, these examinations must give things of information on dosing and peril levels. After preclinical testing, pros study their revelations and pick whether the medicine should be attempted in people.

Sub Tracks:
•    Clinical research ethics
•    Pre clinical drug development planning
•    Finding new drug targets
•    Impact of new technologies on target  discovery
•    Pharmacokinetics

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Clinical Research and Clinical Trails

Clinical research is a part of social insurance science that decides the wellbeing and viability (adequacy) of gadgets, indicative items and treatment regimens proposed for human use. These might be utilized for anticipation, treatment, and analysis or for diminishing indications of a sickness. Clinical preliminaries are look into examinations in which individuals volunteer to test new medicines, mediations or tests as a way to forestall, recognize, treat or oversee different sicknesses or ailments. 
Clinical fundamentals including new drugs are regularly described into four phases. 
•    phase I-Safety of medicine 
•    phase II – Efficacy of medicine 
•    phase III-pre clinical examination 
•    Phase IV – post show packaging.

Sub Tracks: 

•    Phases of clinical trials 
•    Clinical development plan 
•    Objectives & plan of study 
•    Analysis of clinical trials 
•    Ethical principals in clinical research
•    Clinical studies on stem therapy
 

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Clinical Study Designs

It is the definition of preliminaries and tests, just as observational examinations in therapeutic, clinical and different kinds of research including human beings. 
The objective of a clinical report is to survey the security, adequacy, and the system of activity of an investigational therapeutic item or method, or new medication or gadget that is being developed, however possibly not yet endorsed by a wellbeing authority.

Sub Tracks: 

• Cross –section study
• Cohort study
• Case study
• Case control study
• Clinical study protocol

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Patient-Centric Clinical Trials

The intent of patient-centric clinical trials is to lessen the burden of participation by making the participant journey as convenient and pleasant as possible, and, therefore, help in addressing the issues.
There are five steps:
•    Create Patient Profile
•    Crowd source Patients and Caregivers
•    Monitor Online Opinions
•    Work with the Experts to Mitigate Study Burden
•    Simplify and standardize informed consent

Sub Tracks

• Cross –section study 
• Cohort study
• Case study
• Case control study
• Clinical study protocol

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Innovations in clinical Trials

Clinical preliminaries are basic to the discovery   and development of innovative   prescriptions that empower patients to live more, more beneficial lives. As the biopharmaceutical business attempts to distinguish, test and carry new prescriptions to patients, clinical preliminaries are instrumental in deciding the security and adequacy of a potential new treatment.

Sub Tracks

• Pharmacogenomics
• SOP
• ICH
• GCP
• Schedule-Y
   

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Patient Recruiting Retention

•    Patient Recruitment Service Provides to expand enlistment into clinical preliminaries 
•    Patient enlistment is the most tedious part of the clinical preliminary procedure. 
The objective of patient enlistment is to bring issues to light of clinical preliminary openings and to empower enlistment. Administrations are contracted for by pharmaceutical organizations, biotechnology organizations, restorative gadget organizations, contract   inquire about associations (CROs), or a medicinal research site. 
Services include: 
•    Recruitment materials: Patient-legitimately impart intended to draw in study referrals and raise enlistment. It might incorporate leaflets, publications, letters, and flyers. 
•    Media support: Whether coordinated to patients and additionally parental figures,  publication  can raise study  and drive tolerant referral volume. Some patient enrollment suppliers have in-house abilities of creating, delivering, and altering all substance, while others depend on outsider merchants. Some prevalent media for understanding enlistment promoting are: TV, radio, paper, web (e.g., standard advertisements and word joins). 
Persistent   retention – If a preliminary is extensive or on the chance that it requires obtrusive systems, the more noteworthy the requirement for maintenance backing to help keep patients required for the whole preliminary course of events.

Sub Tracks

• Recruitement challenges
• Reason for resistance
• Motivation for participation of clinical trials 
• Achieving recruitments  targets
• Useful tips for participant retention 

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Clinical Data Management and Statistics

It is a basic procedure in clinical research, which prompts age of great, solid, and factually stable information from clinical preliminaries. It guarantees gathering, reconciliation and accessibility of information at proper quality and cost. The primary jobs are answerable for gathering information from an assortment of medicinal research ventures, for example, clinical and pharmaceutical trials. Standard working techniques depict the procedure to be followed in leading information the board exercises and bolster the commitment to adhere to material laws and rules (e.g. ICH,GCP) in the direct of information the executives exercises. Measurements is the study of abridging, gathering, showing and deciphering information in restorative practice, and utilizing them to evaluate the greatness of affiliations and test theories. It has a focal job in therapeutic examinations.

Sub Tracks:

• Data base design and build
• Data resolution 
• Good clinical practice
• Data sharind and achieve
   

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Clinical and Medical Case Reports

Case report is an itemized report of the manifestations signs, analysis, treatment, and follow-up of an individual patient. Case reports may contain a statistic profile of the patient event. Some case reports additionally contain a writing survey of other revealed cases. Case reports are proficient accounts that give input on clinical practice rules and offer a structure for early flag of adequacy, unfavorable occasions, and cost. They can be shared for medicinal, logical, or instructive purposes. 
Types 

• Unique or uncommon highlights of a malady. 
• Unique remedial methodologies.

Sub Tracks:

• Case report forms 
• Benefites of case reporting 
• Medical and research ethics
• Clinical case reports 
   

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Pharmacovigilance and Drug Safety

It is the science identifying with the accumulation, location, evaluation, checking, and counteractive action of antagonistic impacts with pharmaceutical items. It assumes a key job in the pharmaceutical business and the advancement and testing of new medicines. They guarantee that medications available are alright for patients and recognize any issues.

 Seriousness Criteria: 

• Results in death, or is hazardous 
• Requires inpatient hospitalization or prolongation of existing hospitalization; 
• Results in steady or huge handicap or insufficiency; 
• Results in an inherent inconsistency

Sub Tracks:

• Pharmacovigilance enforcement 
• Siginal detection and risk management 
• International conference on harmonization 
• Safety data analysis and reporting
• Periodic safety update reports and risk management 
• Spontaneous reporting 
   

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Data management in Pharmacovigilance

The data management plan describes the activities to be conducted in the course of processing data. The clinical data management system (CDMS) is used for  description of data sources, data handling processes, data transfer formats and process, and quality control procedures to be applied.

Sub Tracks:

• Quality assurance and clinical data management 
• Data management in epidemiology  and pharmacoeconomics
• Sources of reports 
• Triage of reports 
• Safety update reports and annual update reports 

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Drug Discovery and Development

The procedure by which new candidate  prescriptions are found. Present day sedate disclosure includes the distinguishing proof of screening hits, therapeutic science and streamlining of those hits to expand the proclivity, selectivity (to decrease the capability of reactions), adequacy/intensity, metabolic steadiness and oral bioavailability.

Sub Tracks:

• Screening and biological system 
• Drug development process & principles
• High –throughout screening
• Biopharmaceuticals
• Clinical development present & future
• Intellectual property of drug discovery & development 
• Regulatory affairs
   

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CRO or Sponsorship Clinical Trials

It is an organization that offers help to the pharmaceutical, biotechnology, and medicinal gadget ventures as research administrations redistributed on an agreement premise. A support is an individual, establishment, organization or association that assumes the liability to start, oversee or money the clinical trial,but doesn't really lead the examination. CROs are intended to lessen costs for organizations growing new prescriptions and medications into the business sectors. The expect to rearrange passage into medication showcases, and improve advancement, as the requirement for enormous pharmaceutical organizations.

Sub Tracks:

• Investigator brouchers 
• Sponsors indemnity
• Investigational products 

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Clinical Research Informatics

Clinical informatics is the study of information and technology and how it can be applied to the healthcare field and provide treatment to patients.It involves the utilization of informatics in the discovery and management of new information relating to health and diseases. It includes information related to Clinical Trials and informatics related to secondary research use of Clinical data. Clinical informatics applications commonly include informatics ways to approach, process, examine, and show social insurance and biomedical data for research.The health system includes major health domains such as public health, personal health, health professional education.

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Translational and Experimental Clinical Research

It is an interdisciplinary branch of the biomedical field supported by three main pillars: benchside, bedside and community.
Phases of Translational  Research include:

T1 – First stage of Translational   research, in which a foundational discovery or innovation studied in healthy humans 
T2 – The next stage of research translates the finding from people to patients
T3 – This stage focuses on implementation of research discoveries in clinical practice 

T4 – After assessing impacts on practice, this phase of interpretation is focused on influencing populations and policy.

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Clinical Research in psychiatrist

 Clinical Research in psychiatrist mainly focused on the diagnosis, treatment and prevention of mental, emotional and behavioral disorders. Psychiatrists are able to survey both the mental and physical aspects of psychological issues. Psychological health research saves lives, significant distress and improves personal satisfaction. It also benefits the whole society by generating social and economic benefits. Mental health researcher will take part in clinical practice as a course of studying the impacts of intervention, but primary concerns are to understand the causes of psychological disease and the influences them to exacerbate, Develop and test theories regarding intervention, treatment, and prevention.                       

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Pharmaceutical Medicines

A pharmaceutical medicine develops and produces market drugs licensed for use as medications. A global industry, pharmaceutical companies can deal in generic and /or brand medications ,they are subjected  to a variety of laws and regulations regarding the patient testing, and marketing of drug.
Types of route of administration:
Oral, Tropical, Rectal, Inhaled, Intranasal, Vaginal ,Parenteral ,Ophthalmic

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Bioethics and Quality Regulation

It is a part of morals, which is the interdisciplinary investigation of issues made by natural and therapeutic advancement and its effect in the public eye and worth framework, both for the new and future . It worries for moral inquiries include in human comprehension of life. Biosafety is the a version of huge scale loss of natural respectability, concentrating both on biology and human wellbeing.
Sub Tracks:

• Human genomic project and its ethical issues 
• Bioethics and its relations with other branches
• Competence in bioethics
• Principles of biomedical ethics 
   

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Post-marketing Surveillance

It is the act of observing the security of a pharmaceutical medication or therapeutic gadget after it has been released on the market  and it is a significant piece of the study of Pharmacovigilance. Since medications and therapeutic gadgets are endorsed based on clinical preliminaries, which include moderately little quantities of individuals. post marketing  can further refine, or verify  the wellbeing of a medication or gadget after it is utilized in the all inclusive community by huge quantities of individuals who have a wide assortment of ailments. It utilizes various ways to deal with screen medication and gadget security, including spontaneous reporting   databases, prescription event monitoring , electronic wellbeing records, quiet registries and record linkage between wellbeing databases. These information are checked on to feature potential wellbeing worries in a procedure known as information mining.

Sub Tracks:

• History and objective of post marketing surveillance
• Methods of surveillance
• Drug approval process
   

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Research and Trials on Oncology and AIDS

Oncology is the investigation of malignant growth. An oncologist is a specialist who treats malignancy and gives medicinal care to an individual determined to have disease. The field of oncology has three significant regions: 

• Medical 
• Radiation 
• Surgical 

AIDS  research incorporates all medicinal research that endeavors to prevent, treat, or cure AIDS, as well as fundament research  about the idea of HIV as an infectious agent .   AIDS as the disease brought about by HIV. AIDS is caused  by a human immunodeficiency infection (HIV), which began in non-human primates in Central and West Africa.

Sub Tracks:

• Type of multi-arm trials  in oncology
• Cluster  randomized trials 
• Trial deign for rare diseases and small samples in oncology 
• Analysis and quality life outcomes in oncology trials
   

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Globalization of Clinical Trials

Globalization is the procedure of collaboration and mix among individuals, organizations, and governments around the world. As a mind boggling and multifaceted marvel, globalization is considered by some as a type of industrialist development which involves the joining of nearby and national economies into a worldwide, unregulated market economy. Globalization has become more advances in transportation and correspondence innovation with the expanded worldwide communications comes the development of universal exchange, thoughts, and culture. Globalization is fundamentally a financial procedure of communication and mix that is related with social and social aspects. Economically, globalization includes products, benefits, the monetary assets of capital, innovation, and information.

Sub Tracks:

• Global rights and sanctity of life 

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Clinical Trial Site Selection and Management

Clinical preliminary destinations work to serve the two patients and supporters. Clinical preliminary locales are the medications, therapeutic gadgets and different treatments are tried on individuals. The information is then utilized by supporters for FDA Approval of the item. Clinical preliminary the board framework is a product framework utilized by biotechnology and pharmaceutical enterprises to oversee clinical preliminaries in clinical explore. The framework keeps up and oversees arranging, performing and detailing capacities, alongside member contact data, following cutoff times and achievements.

Sub Tracks:

• Clinical site identification and selection
• Site management organization 

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Clinical Trial Forecasting, Budgeting and Contracting

Gauging presents various difficulties: 

• Inability to connect in and update the arrangement dependent on genuine spending. 
• Phasing dependent on a delegate understanding over the whole examination, as opposed to on individual visits and their related expenses for conjecture age. 
• Difficult reconciliation with other money related gauges to display a solidified perspective on the general division. 
• Finance prerequisites, for example, book keeping periods and outside trade rates not very much upheld. 
• Lack of modern book keeping data.

Sub Tracks:

• Financial feasibility 
• Design a staff work schedule 
• Compile of trial budget 
   

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Biomedical Devices Clinical Research

It is an instrument, gadget, machine use for conclusion of diseases. Medical gadgets assumes an essential job in the lives of a huge number of individuals around the world. It's guideline is intricate to a limited extent in view of wide assortment of things that are arranged as medicinal gadgets.
Sub Tracks:

• Electronic signatures and devices 
• Investigational device  exemption 
• Adverse event medical device reporting
• Reframing product life cycle of medical devices
• Medical devices regulatory strategies 
   

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Oncology Clinical Research

Clinical preliminaries in oncology have tradionally focused around the treatment of malignant growth at a specific area in the body, for example, lung or breast disease. It has become common  for preliminaries to concentrate on a particular hereditary transformation at a specific area. Disease endurance has improved because of three principle parts: improved prevention efforts to reduce exposure to risk factors  improved screening of several cancers and improvements in treatment.
Sub Tracks:

• Historical perspectives  of oncology trials
• Noninferioriy trials in oncology 
• Drug evaluation process in oncology
• Adaptive clinical trial design in oncology

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Imaging Research Clinical Research Nursing

Nursing examination is an exploration that gives proof ,used to help nursing researches. Nursing, is  as a proof based region of training, has been creating since the hour of Florence Nightingale to the present day, where numerous medical attendants currently function as scientists situated in colleges just as in the social insurance setting. 
The two all-encompassing objectives are: 

• Helping people of any age to build future and improve their personal satisfaction, 
• Eliminating wellbeing aberrations among various fragments of the populace in the United States.

Sub Tracks:

• Medical imaging in drug development 
• Cardiac imaging in clinical trials 
• Contrast agents in radiology 
   

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Regulatory affairs

Regulatory affairs also called as government affairs, it is a profession within regulated industries ,such as pharmaceuticals, medical devices, agrochemicals, energy, banking telecon  etc..Regulatory affairs also have a specific meaning within the healthcare industries.It plays an important role in pharmaceutical industries because it is concern about the healthcare product lifecycle.
Sub Tracks:

• New drug application 
• FDA regulation 
• Regulatory bodies 
• Validation 

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Clinical Trials Auditing

Observing and evaluating of clinical preliminaries is important to guarantee that the:

• Rights and security of patients (i.e., human subjects) are ensured 
• Reported   preliminary  information  are exact, finished, and detailed preliminary information are precise, finished, and evident from source records. 
• Conduct of preliminary is in consistence with convention, great clinical practice (GCP) and relevant administrative prerequisites. 
• When leading an IND preliminary, the guidelines require the support to screen the investigation.

Sub Tracks:

• Informed Consent Process & Documentation
• Accurate and Complete Study Records
• Determination and Documentation that eligibility criteria are satisfied
• Adverse Event review and reporting
• Closure of study or lapse in approvals while study related activities are still ongoing.
• Drug/Device accountability
• Protocol adherence
• Poor regulatory site documentation
• Failure to address monitor findings
   

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Medical Device Research

It is an instrument,  or creation, including any segment part or accessory to use in the finding, treatment, relief or counteractive action of an ailment, issue or irregular physical state. Medicinal gadgets advantage patients by helping social insurance suppliers analyze and treat patients and helping patients conquer disorder or ailment, improving their personal satisfaction.

Sub Tracks:

• Medical device regulation 
• Design issues in medical devices studies
• Medical device innovation 

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Clinical Research in occupational therapy

Occupational therapy can be described as the art and science of challenging of an individual's effort in specially selected activities that have been designed to restore and enhance his performance. It is  provided to children, adolescents, adults and elderly patients, Psychiatric hospitals, Nursing homes ,Rehabilitation centers ,Special schools ,Community mental health centers.
Goals:
•    Promotion of recovery
•    Mobilization of total assets of the patient 
•    Prevention of hospitalization 
•    Creation of good habits of work and leisure
•    Enhance the patient to regain self-confidence.
  

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Clinical Research in Oral health

The Oral Health Clinical Research Center is to enhance oral health by transferring basic and applied research knowledge and new technical advances into patient-oriented research.It enhance the diagnosis, prevention, and treatment of oral diseases.

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Clinical Research for Surgeon

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