Scientific & systematic collection of data for clinical study is called as Clinical Data Management-
Clinical Data Management-Web Based Data Capture EDC & RDC , Oracle
SAS
Office software
UW Catalyst data collection (University of Washington)
REDCAP (Research electronic data capture)
OPENCLINICA
STUDY TRAX
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Benefits of Using an EDC System
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Benefits of Using an EDC System
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
clinical data management in clinical research, helpful for pharmacy, nursing, medical, health care providers, clinical research organization, PharmD, CROs, Clinical trial industry, human biomedical research.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
Clinical data management (CDM) is a covered part in the clinical trial and most commonly used tools for the purpose of effectivity of clinical research
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
clinical data management in clinical research, helpful for pharmacy, nursing, medical, health care providers, clinical research organization, PharmD, CROs, Clinical trial industry, human biomedical research.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
Clinical data management (CDM) is a covered part in the clinical trial and most commonly used tools for the purpose of effectivity of clinical research
Presentation given by Dr Xin-Yi Chua at the 'Sharing Health-y Data Workshop: Challenges and Solutions' event co-hosted by ANDS and HISA. Held on Wednesday 16th March 2016 at the Translational Research Institute, Brisbane, Australia.
The Use of EDC in Canadian Clinical TrialsKhaled El Emam
Presentation at CHEO Research Rounds on a study to estimate the proportion of Canadian clinical trials that are using an Electronic Data Capture system during the period 2006-2007.
Collecte d’information avec le projet OpenDataKit (ODK)horacio lassey
C'est une presentation de commenter on peut utiliser le projet Open Data Kit ( ODK) pour faire la collecte de données. Ce projet se base sur les terminaux Android pour la collecte des informations.
Integrating Clinical Operations and Clinical Data Management Through EDCwww.datatrak.com
When electronic data capture was first introduced there was a great deal of discussion surrounding how the technology would alter the roles of those in clinical operations and clinical data management. Through the review of a case study, we will explore how EDC is used as a tool to more tightly integrate clinical operational staffs with those in clinical data management resulting in a more streamlined process from study initiation to database lock.
CDM is defined as the process of collection, cleaning, and management of subject data in compliance with regulatory standards.
A database must be accurate, secure, reliable and ready for analysis.
CDMS is the tool for clinical data management.
RESPONSIBILITES OF CDM
STUDY SET UP (15%) - this includes all the activities that are done before at the starting of the study.
STUDY CONDUCT (60%)- this starts once a subject enrollment begins or with first patient‘s first visit.
STUDY CLOSEOUT (25%) -the data is final and ready for statistical analysis.
CASE REPORT FORM
Types of CRF
PAPER CRF
e-CRF
Data entry is a process of entering or transferring data from case report form ( paper or image ) to clinical data management system (electronic storage ).
optical mark reading (OMR)
Data entry may be entirely manual or partly computerized using optical character recognition (OCR).
The three basic types of data entry system:
(a) Local data entry system - data entry is done on site
(b) Central data entry system - data entry is done at data management centre from the received CRFs;
(c) Web based data entry system - data entry is done through web (secure link) using internet connection.
DATA CLEANING
MANAGING ADR DATA
ADR data are collected from clinical trials and marketed products.
All ADR are reported to clinical data management system or safety system.
During clinical trials-ADR information is also received through CRF or EDC.
These information are stored in clinical data management database.
DATABASE LOCK PROCESS
Data manager – data is accurate and complete
Clinical project manager – site activities are complete
Medical monitor - data is medically accurate
Biostatistician - data is ready for evaluation and analysis.
Data manager asks for the database to be locked .
Done through the company’s IT department.
Once locked, no data can be changed.
Signed process for locking the database is placed in Trial Master File (TMF)
Data base closure (database lock): The database closure for the study is done to ensure no manipulation of study data during final analysis.
DATABASE LOCK/FREEZE is a TWO step process:-
The first step is often referred as SOFTLOCK or DATABASE FREEZE- occurs after all data cleaning, validation, and QC activities have been finalized.
The second step is called HARDLOCK or DATABASE LOCK –At this stage the database is handed over to statistics for data analysis.
DATA TRANSFER
Traditional Data Transfer
CRFs developed by sponsor and supplied to the site along with completion/instruction manual .
Use a black or blue ball point pen for permanency – and PRESS HARD.
At the time of a monitoring visit, CRFs are reviewed for adherence to
guidelines and verified against source documents by the Monitor.
During the monitoring visit, site staff make required corrections to CRFs
Verified/corrected CRFs are submitted to the sponsor, leaving a legible
copy of the CRF at the site.
an explanation of the barcoding pipeline, what data objects need to be tracked through the pipeline, and the possible entry and exit points to the pipeline
Who needs fast data? - Journal for Clinical Studies KCR
How “no news” during the life of a trial is bad news, and what data management (among other things) can do to help when ensuring access to fast data? Get to know this and more about smart e-solutions in the newest article of Kaia Koppel, Associate Director, Biometrics & Clinical Trial Data Execution Systems at KCR, in the recent issue of Journal for Clinical Studies (p.40-21).
View this recorded webinar to hear an overview of the Guidance Document on Electronic Source Data in Clinical Investigations and its practical implementation.
Pine Biotech conducts monthly informational workshops on the topics related to high-throughput data analysis, interpretation and integration. The workshops highlight our research tools and educational resources developed with collaborators in the US and across the world.
T R I A L M O N I T O R I N GQuality Remote Monitoring .docxssuserf9c51d
T R I A L M O N I T O R I N G
Quality Remote Monitoring:
The Tools of the Game
Penelope Manasco, MD
Outlining those technologies best able to raise the
data and process quality of risk-based monitoring.
A
critical aspect of risk-based monitoring
(RBM) is rapid access to a site’s clinical
data. In 2013, industry median values from
2009-2012 Phase II and III clinical trials (see
Figure 1 on facing page) showed that the
median time from electronic case report (eCRF)
entry to data manager query opened was 59 to 89
days. This is even more extraordinary when one
considers that the median time from subject visit
to query close (all queries including automatically
generated queries) ranged from 30 to 36 days.'
These findings emphasize that direct data en
try, either into the electronic data capture (EDC)
or eSource systems, provides significant value in
overseeing study conduct quality. Mitchel et al.2
reported on their experience implementing direct
data entry (DDE) and RBM in a clinical trial of 18
investigative sites in the U.S. and Canada study
ing 180 research subjects. In that trial, 92% of the
data was entered within one day of the subject
visit and 98% within eight days. Data review was
also faster with 50% of the data reviewed within 13
hours of data entry. Source data verification (SDV)
was completed at the site for approximately 20%
of the data within the EDC. There were changes on
0.8% of the pages, with the majority in three areas:
concomitant medications, medical history, and
clinical laboratory results.
The evidence above, coupled with the find
ing that SDV was not an adequate approach to
ensure trial quality,5 illustrates the importance of
technology and process changes that should be
implemented to enhance remote trial oversight
as envisioned by the FDA,2 European Medicines
Agency (EMA),5 and International Conference on
Harmonization (1CH) guidance6 documents on
RBM and quality management. The following tech
nology solutions can provide significant benefits
to implementing RBM and remote trial manage
ment.
Technology solutions
EDC and eSource
Direct data entry can be accomplished though
web-based EDC solutions and tablets, it is imper
ative that sites have adequate Internet access to
use tablets for direct data entry. Sites benefit from
eliminating transcription of documents. Moni
tors and data managers also benefit from having
immediate access to the data. Questions that
document good clinical practice (GCP) compli
ance can be incorporated into the EDC or eSource.
These fields (e.g„ detailing timing for vital signs,
informed consent processes) enable monitors to
conduct source data review remotely. Many data
managers may not be familiar with the additional
questions the monitor will want to have docu
mented, so cross-functional input into the EDC
is needed during design. Tablet setup and testing
ensures tablets work as needed by the site. The
initiation visit should i ...
Labmatrix is a software application that manages the operational aspects of collaborative clinical and translational research programs, including patient recruiting, consenting, sample management (biobanking), experimental characterization of the samples and tracking of patient clinical profiles.
Regulating eDiaries from Planning to Retention of Archival eSource Records
by Stephen A. Raymond, PhD
Chief Scientific Officer and Founder
PHT Corporation
Flattening the Curve with Kafka (Rishi Tarar, Northrop Grumman Corp.) Kafka S...confluent
Responding to a global pandemic presents a unique set of technical and public health challenges. The real challenge is the ability to gather data coming in via many data streams in variety of formats influences the real-world outcome and impacts everyone. The Centers for Disease Control and Prevention CELR (COVID Electronic Lab Reporting) program was established to rapidly aggregate, validate, transform, and distribute laboratory testing data submitted by public health departments and other partners. Confluent Kafka with KStreams and Connect play a critical role in program objectives to:
o Track the threat of COVID-19 virus
o Provide comprehensive data for local, state, and federal response
o Better understand locations with an increase in incidence
Integrated research data management in the Structural SciencesManjulaPatel
A presentation given by Manjula Patel (UKOLN, University of Bath) at the I2S2 workshop "Scaling Up to Integrated Research Data Management", IDCC 2010, 6th December 2010, Chicago.
http://www.ukoln.ac.uk/projects/I2S2/events/IDCC-2010-ScalingUp-Wksp/
Pristyn Research Pvt Ltd is a contract research organization specialize in providing tailored clinical research and pharmaceutical development solutions to both the inventor and pharmaceutical industries. With a legacy of years of excellence, we have consistently empowered global enterprises to elevate their regulatory and clinical research endeavours, delivering impactful and high-quality data. Pristyn Research is a professional and reliable name in the pharmaceutical and research industry. We strive to produce validated medical data for research & dedicated professionals.
Our comprehensive suite of services extends beyond clinical trials and operational support. We are your one-stop destination, offering medical writing, regulatory guidance, and scientific research services. We provide a complete package, spanning the journey from drug discovery to regulatory approval, including crucial tech transfer processes. Our impressive track record boasts numerous successfully completed clinical studies and research projects, encompassing vital areas such as medical device testing. We've been instrumental in helping numerous sponsors navigate the complexities of regulatory approvals, ensuring their innovations reach the market.
Pristyn Research is a legally established corporation under the laws of India and proudly bears the registered trademark "Pristyn Research®." Notably, we have recently integrated the esteemed "Pristyn Research Solutions," a renowned leader in corporate training for research and development. Our international affiliations and regional government approvals for training programs underscore our commitment to excellence in education and development. Our vast network of representatives and affiliates spans across various sectors, including corporate, public, private organizations, and professional bodies. This expansive reach reflects our dedication to fostering collaboration and innovation within the clinical research and development domain. In summary, Pristyn is your trusted ally on the journey of scientific discovery and innovation. With a rich history of accomplishments and a forward-looking approach, we are poised to continue making significant contributions to the world of research and pharmaceuticals, consistently raising the bar for excellence.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
COMMON REGULATORY AFFAIRS
JOB INTERVIEW QUESTIONS WITH
ANSWERS By Pristyn Research-Updated 2022.
A quick Job interview short guide For Pharma and all
Life science jobseekers.
info.pristynresearch.com
www.pristynresearch.com
9028839789 | 8999717656
All Medical | Biotech |Micro |B.Sc., M.Sc.
PAN India DRA companies
list alphabetically
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 9028839789
Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
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NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
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GRANULES
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BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
These are the commonly asked questions with their answers asked in any job interviews. The file is updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Sample Questions are:
Tell me about yourself?
What are your Career Goals?
Why have you been unemployed for such a long time?
Are you a team player?
Describe your management
style?
What irritates you about co
workers?
What position do you prefer
while in a team working for
project?
Do you consider yourself
successful?
what are your strengths?
what are your weaknesses?
why you left your previous job?
why we should hire you?
are you a complete fresher?
Tell me about your ability to work under pressure?
How long would you expect to work for us if hired?
What are your expectations from a job?
How do you see yourself 5 years from now?
What are your Salary Requirements?
What will you do if we reject you?
DO you have any questions for Us?
Answer it like: If selected: Yes I do, when can I join?
If rejected: Yes I do, rejection is an
opportunity to learn. I will request
you to kindly tell me the reason why I am being rejected today? I will work on my shortcomings and may one day be a part of your
organization.
What is scientific research writing?
Answer: It is the technical writing that scientists do to communicate their research to others [1].
What is a research manuscript?
Answer: A systematic inquiry document that entails collection of data; documentation of critical information; and analysis and interpretation of that data/information, in accordance with suitable methodologies set by specific professional fields and academic disciplines [2].
What is a review article?
Answer: A literature review article is a comprehensive summary of previous research on a topic. It is assumed that by mentioning a previous work in the field of study, that the author has read, evaluated, and assimiliated that work into the work at hand [3].
What is peer review paper?
The peer review paper is a validation of academic work, helps to improve the quality of published research, and increases networking possibilities within research communities [4].
What is meta-analysis?
Answer: A subset of systematic reviews; a method for systematically combining pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion that has greater statistical power [5].
What dissertation?
Answer: A thesis is a hypothesis or conjecture. A PhD dissertation is a lengthy, formal document that argues in defense of a particular thesis. Two important adjectives used to describe a dissertation are ``original'' and ``substantial.'' The scientific method means starting with a hypothesis and then collecting evidence to support or deny it [6].
What are journals?
Answer: A research journal is a periodical that contains articles written by experts in a particular field of study who report the results of research in that field [7].
What does publisher mean?
Answer: Authors and publishers will generally have a publishing agreement (sometimes referred to as an author or licence agreement) in place when a work is published [8].
What is ISSN number?
Answer: An ISSN is an 8-digit code used to identify newspapers, journals, magazines and periodicals of all kinds and on all media–print and electronic [9].
What is volume of a journal?
jobs
INTERVIEW
SOFTSKILLS
BODY LANGUAGE
EYE CONTACT
POSITIVE ATTITUDE
SITTING POSTURE
SMILE
SELF CONFIDENCE
PUBLIC SPEAKING
GOOD DECISION
TIME MANAGEMENT
PUNCTUALITY
PROFESSIONALISM
RESPECT
RESPONSIBILITY
SKIN & BODY CARE
Make-up Hygiene
jobs
INTERVIEW
SOFTSKILLS
BODY LANGUAGE
EYE CONTACT
POSITIVE ATTITUDE
SITTING POSTURE
SMILE
SELF CONFIDENCE
PUBLIC SPEAKING
GOOD DECISION
TIME MANAGEMENT
PUNCTUALITY
PROFESSIONALISM
RESPECT
RESPONSIBILITY
SKIN & BODY CARE
Make-up Hygiene
SYNTHESIS, CHARACTERIZATION, AND STUDY OF ELECTRICAL
CONDUCTIVITY AND THERMOGRAVIMETRIC ANALYSIS OF
CONDUCTING POLYMER COMPOSITES WITH FLY ASH
- A Ph.D. PRE SUBMISSION SEMINAR-
Communication and Soft Skills in Pharma industry are most important to fill the vacuum created due to lack of facilities and guidance during the degree course. To prove the power of personality, Professionalism, Sovereignty, and Excellence in all walks of life for yourself and thus strengthen the shining future of your career and our Country.
NEW DRUG DEVELOPMENT
WHAT DOES DRUG MEAN?
TRADITIONAL SYSTEM OF MEDICINES
NEW DRUG DEVELOPMENT PROCESS
PHASES OF CLINICAL RESEARCH
OVERVIEW OF EACH PHASE
PHASE-0
PHASE-1
PHASE-2
PHASE-3
PHASE-4
CONSIDERATION BEFORE STARTING CLINICAL RESEARCH
AIMS AND OBJECTIVES OF EACH PHASES
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
https://www.youtube.com/watch?time_continue=4&v=F4jiJD0O8T8
NEW DRUG DEVELOPMENT
Clinical Research - Phases
New Drug Development Process
CONTENT OF INDA
CONTENT OF NDA
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON 09028839789
FOR ENROLLMENT IN NEXT BATCH KINDLY CONTACT US ON THE ABOVE MENTIONED CONTACT NUMBER
http://pristynresearch.com/
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
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LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
DRUG AND COSMETIC ACT -
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
DRUG ACTION
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
CLINICAL RESEARCH IS ONE WHICH MADE POSSIBLE , ORAGAN TRANSPLANT, MANAGE OF DIBETIS, ADDED YEAR OF AIDS PATIENT.
HOW WELL NEW APPROCHES AND WORK IN PEOPLE.
THE APPROACHES CAN BE MEDICAL, BEHAVIORAL, OR MANAGEMENT.
EACH STUDY ANSWER SCIENTIFIC QUESTION.
GENERAL INTRODUCTION OF CLINICAL RESEARCH
KEY POINTS AND CONCEPTUAL DEFINATION
DRUG DISCOVERY PROCESS
SOURCES OF DRUG DISCOVERY
PRECLINICAL STUDY
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Clinical data management web based data capture edc & rdc
1. Web Based Data Capture EDC & RDC
Presented by:
Pristyn Research Solutions
www.pristynresearch.com
2. SOFTWARE USED
1. Oracle
2. SAS
3. Office software
4. UW Catalyst data collection (University of Washington)
5. REDCAP (Research electronic data capture)
6. OPENCLINICA
7. STUDY TRAX
8. etc.
22. Most clinical research lab data is electronically entered directly into a
computer, with the electronic data file serving as the source data.
23. Clinical research data captured directly from the subject can be entered in two
steps via (1) paper case report form to (2) computerization, or in one step (1a)
directly into the computer.
24.
25.
26.
27.
28.
29. Difference between e-process and paper process
Paper CRF:
Electronic data collection:
protocol CRF Database Data evaluation DB lock
Data Analysis
Data entry
Conduct the trial
protocol eCRF/ Database Data evaluation DB lock Data Analysis
Data entry Conduct the trial
