- ➔ Clinical Trials/ Clinical Research
- ➔ ICH GCP Guidelines
- ➔ Clinical Data Management
- ➔ Pharmacovigilance
- ➔ Medical Writing/Coding
- ➔ SAS
- ➔ CDISC-SDTM, ADaM
- ➔ TLF’S.
A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.
Yes, the term clinical trials also refer to clinical research.
A clinical trial is conducted in a phase-wise manner. There are four phases of a clinical trial (I,II, III, and IV) each designed to address different questions. The knowledge gained from one phase is assessed before progressing to the next phase. Phase-I clinical trials are generally done to establish the initial safety of a drug usually on healthy human volunteers. Phase-II and Phase- III clinical trials are done to establish the safety and efficacy of a drug in patients with relevant indication.Phase-IV clinical trials are post marketing studies done to collect the additional safety data on a drug after its marketing authorization.
Ans :- These are the following four phases of the clinical trials:
Phase 1: Test a new drug or treatment to a small group of people (20-80) to evaluate its safety.
Phase 2: The experimental drug or treatment is given to a large group of people (100-300) to see that the drug is effective or not for that treatment.
Phase 3: The experimental drug or treatment is given to a large group of people (1000-3000) to see its effectiveness, monitor side effects and compare it to commonly used treatments.
Phase 4: The 4 phase study includes the post marketing studies including the drug's risk, benefits etc.
Clinical research studies/clinical trials are generally conducted by pharmaceutical companies,biotech companies, contract research organizations (CROs), medical device companies,cooperative groups, research and academic institutions etc.
An organization (commercial, academic, or other) contracted by the pharmaceutical manufacturer/sponsor to perform one or more of a sponsor's clinical trial-related activities. There are hundreds of large and small CROs, all of them employing CRAs, CRCs and CDMs.
Recent trends in clinical research industry are suggestive of employment preference to the personnel having a basic orientation and certification of clinical research. A basic level clinical trials training not only increases the visibility of the CV but also provides the required knowledge/skills to address the specific questions during the interview.
As the entry in clinical research filed is largely dependent on the basic educational qualification of a candidate, the important factors to be considered while selecting a clinical research training institute/course include: duration of the training program, reliability of the training program/institute in terms of years of existence, quality of training and relevant industry experience of the core faculty; and mode of the training in terms of the ease of undertaking it along with other commitments.
Yes, you are eligible. People with B.Pharmacy, M. Pharmacy, Pharm D, B.Sc, M.Sc, B.Tech(Biotech), M.Tech(Biotech), MBBS, BDS, BHMS, BAMS, BMS, BPT, Nursing etc are all eligible.
The entry level job positions include clinical research coordinator (CRC) position at Investigator site level and clinical trial administrator (CTA) or trainee clinical research associate (CRA) position at Sponsor/CRO level. Career growth at Sponsor/CRO level includes the positions of Senior CRA, Project Manager, SAS programmer, Statistical Programmer, Clinical Data Manager, Clinical Data Associate, Database Programmer, Pharmacovigilance Associates/Managers, Saftey Associates/Mangers,Team Leader, Quality Assurance, Manager-Clinical Operations and Director/Vice President etc.
A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor. The title will vary from company to company. The job description will be the same. A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials.
Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and/or experience to monitor their studies per Good clinical practice and local regulations. It also states that Monitors be appropriately trained and their qualifications documented. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex. In India he / she require knowledge about schedule Y amendments in drug and cosmetic act 1945.
- ➔ To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
- ➔ Assure the protection of the rights, safety and well being of human study subjects.
- ➔ Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
- ➔ To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
- ➔ To make certain that the scientific integrity of the data collected is protected and verified.
- ➔ Assure that adverse events are correctly documented and reported.
- ➔ Review all case report forms and compare them to source documents.
The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI).CRCs:
- ➔ Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- ➔ Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- ➔ Code, evaluate, or interpret collected study data.
- ➔ Track enrolment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- ➔ Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- ➔ Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- ➔ Oversee subject enrolment to ensure that informed consent is properly obtained and documented.
- ➔ Maintain contact with sponsors (CRAs) to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- ➔ Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- ➔ Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines.
These are international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects.
Clinical trials are conducted according to Good Clinical Practices (GCP) Principles ensuring that:
- ➔ All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
- ➔ Benefits outweigh risks for each patient.
- ➔ Rights, safety and well-being of patients prevail over science.
- ➔ All available non-clinical and clinical information on any investigational agent can support the trial as designed.
- ➔ All trials are scientifically sound and clearly described.
- ➔ All clinical trials have current Institutional Review Board approval.
- ➔ Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians.
- ➔ Everyone involved in the clinical trial is qualified by training, education and experience.
- ➔ Informed consent is given freely by every participant.
- ➔ All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
- ➔ Confidentiality of subjects is respected and protected.
- ➔ Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
- ➔ Systems to ensure quality are implemented in all aspects of the trial.
The Clinical Data Manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.
The CDM is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the clinical data manager ensures that data is collected, validated, complete and consistent.
The CDM liaise with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data manager transfers data for statistical analysis.
- ➔ Serves as the primary Clinical Data Management contact with sponsors and represents CDM on project teams.
- ➔ Responsible for timelines, reporting and data collection.
- ➔ Coordinates the receipt and processing of information for projects (e.g., coding dictionaries) as well as electronic data capture.
Ensure databases are validated and ready for transfer and/or analyses.
Base SAS, SAS Macro, SAS SQL, SAS Graph and additionally clinical domain sessions and most importantly case studies.
USFDA as a regulatory body has got compliance from SAS reports and moreover SAS has been approved by USFDA as they accept the format of reports which can be provided by SAS.
Base SAS, Advance SAS (SAS Marco, SAS SQL and SAS Graphs) clinical domain sessions and some case studies
The modules are SDTM and ADaM.
To help in streamlining the Clinical data lifecycle by leveraging emerging industry data standards with strong domain and technological expertise. This in turn, helps the sponsor towards production of regulatory grade products throughout all stages of the Clinical Data Lifecycle.
ODM: Operational Data Model. Standards for data storage formats.
SDTM: Study Data Tabulation Model
CRT-DDS: Case Report Tabulation Data Definition Specification
ADaM: Analysis Data Model
SEND: Standards for exchange of Non-clinical data
CDISC stands for Clinical Data Interchange Standards Consortium and it is developed keeping in mind to bring great deal of efficiency in the entire drug development process. CDISC brings efficiency to the entire drug development process by improving the data quality and speed-up the whole drug development process and to do that CDISC developed a series of standards, which include Operation data Model (ODM), Study Data Tabulation Model (SDTM) and the Analysis Data Model ADaM).
CDISC’s Study Data Tabulation Model (SDTM) has been developed to standardize what is submitted to the FDA.
To standardize clinical data. To bring uniformity and vendor neutrality in clinical data To bring ease and cost effectiveness into data exchange Easier submission and faster evaluation of CDISC compliant data by the regulatory bodies.
Generally speaking, only about 30% of programming time is used to generate statistical results with SAS®, and the rest of programming time issued to familiarize data structure, check data accuracy, and tabulate/list raw data and statistical results into certain formats. This non-statistical programming time will be significantly reduced after implementing the CDISC standards.
With the new requirements of electronic submission, CRT datasets need to conform to a set of standards for facilitating reviewing process. They no longer are created solely for programmers convenient. SDS will be treated as specifications of datasets to be submitted, potentially as reference of CRF design. Therefore, statistical programming may need to start from this common ground. All existing programs/macros may also need to be remapped based on CDISC so one can take advantage to validate submission information by using tools which reviewer may use for reviewing and to accelerate reviewing process without providing unnecessary data, tables and listings. With the new requirements from updating electronic submission and CDISC implementation, understanding only SAS® may not be good enough to fulfill for final deliverables. It is a time to expand and enhance the job skills from various aspects under new change so that SAS® programmers can take a competitive advantage, and continue to play a main role in both statistical analysis and reporting for drug development.
A list of basic variable mappings is given below:
DIRECT: a CDM variable is copied directly to a domain variable without any changes other than assigning the CDISC standard label.
RENAME: only the variable name and label may change but the contents remain the same.
STANDARDIZE: mapping reported values to standard units or standard terminology
REFORMAT: the actual value being represented does not change, only the format in which is stored changes, such as converting a SAS date to an ISO8601 format character string.
COMBINING: directly combining two or more CDM variables to form a single SDTM variable.
SPLITTING: a CDM variable is divided into two or more SDTM variables.
DERIVATION: creating a domain variable based on a computation, algorithm, series of logic rules or decoding using one or more CDM variables.
Annotated CRF is a CRF (Case report form) in which variable names are written next the spaces provided to the investigator. Annotated CRF serves as a link between the raw data and the questions on the CRF. It is a valuable tool for the programmers and statisticians.
Ans: - We can generate the listings by using the PROC REPORT. Similarly we can create the tables by using PROC FREQ, PROC MEANS, and PROC TRANSPOSE and PROC REPORT. We would generate graph, using proc Gplot etc.
The CDISC Analysis Data Model (ADaM) defines a standard for Analysis Dataset’s to be submitted to the regulatory agency. This provides a clear content, source, and quality of the datasets submitted in support of the statistical analysis performed by the sponsor.
There are opportunities in Clinical Research Organizations, Pharmaceutical and IT companies (Information technology).
SAS Programmer (Clinical), Statistical Programmer, CRA, Data Analyst, Technical Analyst, Data Processor, Clinical Research Coordinator (CRC), CRA Manager, Project Manager, Research & Development Project Managers, GCP QA/QC Auditors, Data Managers/Biostatisticians, Regulatory Affairs & Compliance Professionals, Safety Managers, Corporate Managers, Clinical Research Trainers, Clinical Site Managers and Business Development Professionals etc.
It will depend on the individual company, Organization where you are hired. A CRA or CDM can either work from the company headquarters, a branch location specifically for CRAs and DMs, or from their own home.
Depends on the modules you choose:
- ➔ CR & CDM – 45 Days
- ➔ Pharmacovigilance with Argus – 60 Days
- ➔ (Base and Advance) - two months
- ➔ SAS with Domain - Three months
Yes of course. We do offer weekend classes as well as online classes.
We provide placement assistance in IT Companies / Pharmaceutical Companies and CRO’s.
Faculty is our strength. All our instructors are professionals with 10-15 years of working experience. We handpick the trainers, who are experienced, have passion for training and who possess excellent training skills. All our trainers are considered to be the best faculty of the industry.
Yes, you will be getting the certification after successful completion of course – Clinical Research and Data Management but for SAS companies are asking for Global Certification.
Yes, off course but in order to do SDTM you require to know SAS and Domain.
We will address your problem. In our course we have included sessions like Presentation skills, Interview skills, Resume preparation and also Mock Interviews before any company Interviews etc.
With the experience working with CRO’s, we have designed each training module focusing to expose the students practically to each task with logical exercises covering all the areas of Clinical Trials, PV and Clinical Data Management, CDISC-SDTM and SAS. Also the training content which iGCP provides is incomparable with any other training institute.
We understand the exact requirement of the Clinical Research Industry for their need of the trained manpower as we have experience working with Clinical Research Industry since 10 years handling Clinical Trials, Clinical Data Management, SAS, Pharmacovigilance, Drug Regulatory Affairs etc
No. You are not required to know coding of any computer language in order to do these courses.
Yes certification is useful. In order to get job ready, certification has to be completed and will be added advantage to your profile.
The salaries are in the range of 3.0 to 4.0 lakhs per annum along with attractive growth path for fresher’s but you can get up to 20-25 lakhs per annum based on the experience.
In fact they do better in SAS because of their Clinical Domain knowledge.
In Clinical SAS students with life science background are preferred and also other graduates.
YES. Engineering graduates often have good analytical and problem solving skills. They will need to update clinical domain knowledge.
Quintiles, Cognizant, Nova-Nordisc, Icon, GSK, Novartis, ClinAsia, Paraxel , Accenture, TCS, Inventive, Tech Mahindra, Genpact, Biocon, Chiltern, MMSH and many more..
iGCP conducts periodical demo sessions on all the courses. Request a demo by Registering in the website. We will share the demo details.
Send us an email firstname.lastname@example.org with your query. Our Subject Matter Experts/Sales team will approach you to clarify your queries or call us on 9030070095, 8790209568.
We don’t wash off our hands after the completion of the training. A dedicated trainer will be provided as mentor to guide you subsequent to the training. Faculty will do the necessary handholding to clarify all your doubts. In addition you can approach our support team to answer your queries. We will be more than happy to assist you.
Clinical/Healthcare field is the least affected field in spite of global recession.
Both. Classroom and Online.
Yes you can shift field. However there are more candidates who shift to SAS programming after working in CDM, because of the better career growth with SAS programming field.
We are located at Hyderabad but we do also offer online training.
NO company would like to spend time to train the fresher’s because they have time lines for deliverables. So, highly experienced staffs (SME’s) from clinical research and data management industry will only will involved in training the candidates for 90 days with hands on experience on various areas of Clinical Data Management, SAS, CDISC-SDTM/ADAM. So students trained by IGCP students with 3 months experience are preferred over the fresher’s
Yes, you can work in IT Companies through SAS, Clinical Data Management and CDISC-SDTM.
Yes, you are eligible. You can opt for this course and you will have better career options from what you have now.
Yes, of course. You can opt for course on Weekends or Online Classes.
Let us talk about the possibility of getting a job. The jobs in the market are governed by demand- supply gap. If there is more demand than the supply, jobs are available quickly, where as if the supply is more than the demand obviously, more time is required to get placed. At the moment lot of work is being outsourced to India and there is less number of trained SAS programmers. Hence EVERY TRAINED SAS PROGRAMMER GETS PLACED.As a student, one has to make sure to put in the best to learn and derive advantages.
Both students and professionals can avail this facility. There will be full time course/week end course and also online classes.
Yes, we provide 100% placement assistance to all our students who successfully complete course from us.
No, Your Placement Activity starts from 2 nd Month itself.
AICTE accreditation is meant for technical courses and to that extent you have your degrees from AICTE/ UGC. Institute like us are meant to enhance your skills and knowledge which are already embedded in you. So go by the institutions existence, most important is the quality of training.
No, not at all. We don’t believe in this practice. So reference helps you in some cases to move your candidature further. As at the end of the day you are the one who will take up the interview.
Yes, we provide course material and exercises to practice.