Certificate in Clinical R Programming

Cytel team in India is growing by leaps and bounds and today Cytel India grows to a team of 400 people spread across current locations in Pune, Hyderabad, Bangalore and Navi Mumbai. Cytel has expanded its delivery from the core SAS Programming and statistics to other clinical domains such as Clinical R Programming, data management, medical writing areas. Cytel’s growth in services is supported by CliPLab – Cytel’s unique skill development machinery by introducing various industry focussed training and skill development programs. In a newly announced program titled C-ClinR  (Certificate in Clinical R Programming) spanning over 6 weeks, CliPLab provides theory and practical training to young graduates/professionals, who are hand-picked to ensure a mix of the right pool of talents with correct aptitude and skill set. The program helps participants to enhance the competency and credibility as a technical professional by attaining relevant practical and theoretical knowledge. 

Why Clinical R Programming ?

R Programming, an open-source tool, is extensively used for data analysis in universities. Professors and researchers in the field of medicine use R for quantitative analysis. Google and Facebook use R Programming for data exploration, model prototyping and predictive analytics. It is the main programming tool for many quantitative analysts in the finance domain. R Programming is a powerful tool with numerous applications: data import and cleaning, exploration and visualization, statistics generation and analyses and trading simulations. Thus, it is popular in varied fields such as finance, bio-science, clinical and life science, supply chain, sports, retail, marketing and manufacturing. 

The two main advantages of R are;

1.       It has been designed specifically for statistical analysis; therefore, programs in R always require fewer lines of code than programs created using other analytical tools.

2.       It is an open-source tool; therefore, it benefits from constant upgrades, improvements, enhancements and contributions from a global community of passionate users and developers.

Using R in a Clinical and Regulatory Environment

The Office of Biostatistics, US FDA, uses R on a daily basis. FDA scientists have written R packages that can be used by other scientists (FDA or non-FDA). It is a popular misconception that the FDA mandates or endorses the use of a specific software package for statistical analysis – this is not true. The FDA in fact encourages using anything that can be validated for correctness, including R. 21 CFR Part 11 regulates electronic records and their storage, not the software that is used to generate reports. No regulation restricts the use of open-source software (including R) at the FDA.

Meanwhile, in the pharmaceutical and clinical research domain, SAS Programming enjoys immense popularity and is widely used, although regulations do not specify or endorse the use of either SAS or R programming software for statistical analysis and generation of reports and graphs. Owing to the advantages and ease of use of both these tools, various organizations are creating talent pools that are trained in both SAS and R Programming.

Considering this, CliPLab launched “ClinR”, a new course in Clinical R Programming and welcomes candidates to join this course. At CliPLab, we are aware that R requires a data analysis background, and therefore, it must be taught in a manner different from Java or Python. Hence, we use relevant clinical datasets as examples and exercises in the ClinR module.

Duration: 6 weeks / 30 hours / Weekend Program (4 hrs on each week end)

Eligibility: Candidates are preferred from:

·         Pharmacy (M. Pharm., B.Pharm.,)

·         Life sciences (M.Sc., PhD - Biotechnology, Bioinformatics, Microbiology)

·         SAS Programmers / Biostatisticians / Data Science professionals

·         Life Science Students / Researchers / Faculties in colleges and universities

Program Outline

The ClinR course module consists of the following topics:

Module	Topic
1.	Introduction to R
2.	Basics of R
3.	Data Structures
4.	Reading Data in R
5.	Writing R Functions
6.	Control Statements
7.	Loops
8.	Group Manipulation
9.	Data Reshaping
10.	Manipulating Strings
11.	Probability Distributions
12.	Basic Statistics
13.	R Graphics
14.	Report Generation

Features of the ClinR course

·         Specially designed for Life Sciences domain by Cytel, a global expert in biostatistics and clinical programming

·         Comprehensive and top-notch Clinical R Programming training

·         Experienced trainers, who are proficient clinical R programmers with exposure to global clients, including large pharmaceutical and biotech companies

·         Coverage of fundamentals of clinical operations and basic statistics

·         Practical exposure to R Programming using clinical data sets and case studies

·         Regular assessments to improve and evaluate performance

Program Fees:

• This self-financed program would require the investment of Rs. 25,000/- + Applicable tax

Mode of Payment:

o    Payment can be done by Cheque/DD/Credit Card/Debit card/Online Transfer

A Promising Career Avenue for graduates from Pharmacy and Life Science

For graduates and post-graduates from Life Science and Pharmacy streams, there are multiple avenues where an individual can launch a career. We have tried listing down the fields where such professionals are welcome and can make a meaningful contribution. Some of the prominent roles are - Laboratory Staff, Microbiologist, Chemist, Medical Representative, Pharmacist, QA officer, QC officer, Production Chemist, Professor. It is surprising to find so many career options available for graduates with  differing talents and interests to make a meaningful career.

However, none of the professions listed above open doors for graduates who are interested in switching to a career in programming. On the contrary, we have experienced time and again that the candidates from Pharmacy and Life Sciences have done or are likely to do extremely well in the Clinical Trial Programming field. Thanks to the ever growing Clinical Research industry, things have started changing rapidly. India is moving from being a generic bulk drug manufacturer to one of key players in Clinical Research being conducted across the world. An indispensable stage in the  Clinical Research and Drug Development is the analysis of the data gathered during the Clinical Trial and generation of study reports  that are to be submitted to Drug Approval Authority such as FDA in US. The most commonly used software for the analysis and reporting is SAS. Thanks to high availability of skilled resources, innovative capacity and reduced costs, we anticipate India (and more generally Asia), with its large pool of young, talented human resource, will spearhead the growth of this segment.

If you have good aptitude, strong domain knowledge in life science and a passion to build a different career, this is an excellent opportunity for you.

There are three reasons why Clinical Trial Programming is a viable career option for you:

1. It complements well your educational background – The domain knowledge you have acquired during your formal education actually puts you at an advantage over other programmers working in this area

2. The field provides a sustainable and highly rewarding career roadmap.  The competent professional can rise up the ranks in the corporate matrix and the only limiting factor is your performance, potential and attitude.

3. The field offers a handsome remuneration and perks that typically are part of a career in Information Technology. These perks include a market competitive salary package, opportunity to attend and present seminars at international conferences  and deployment to overseas locations., 

At Cytel, we have many examples of Pharmacy Graduates who have made an illustrious career in the Clinical Trial Services field. CliPLab, the strategic skill-building unit of Cytel, is working with a mission to help the deserving candidates make a foray into this challenging and rewarding industry. To know more on this topic, you can visit our website or send an email at info@cliplab.co.in

About the author: Nakshatra Vinod, a Postgraduate in Microbiology and Psychology, is working with CliPLab as a Team Lead. Her expertise lies in counseling the students on career opportunities in clinical trial industry and coordinating the operations at the Hyderabad centre of CliPLab.

First C-CAP Batch in Pune Felicitated

We recently organized the convocation ceremony for our very first C-CAP batch from Pune. The students were looking forward to this event for a long time – so much that some of them travelled from Mumbai and Noida just to resurrect some of the great moments of their student lives.  The event was also attended by our existing students who were thrilled with the opportunity to hear the experiences of their seniors as they stepped into the corporate world.

The guest of honor for the ceremony was Mr. Ajay Sathe (CEO, Cytel India) who happily agreed to grace the occasion and share his valuable thoughts for a successful career with the young graduates.

The young graduates have undergone a rigorous training program in  SAS^® 9.4 followed by hands on  experience and on-the-job training at Cytel Statistical Software & Services Pvt Ltd. The C-CAP program has groomed them on various facets of a successful career in Clinical Programming – Domain Knowledge, Statistics Awareness, Therapeutic Areas, Industry Standards, Practical Assignments and Soft skills. The comprehensive structure of the program has ensured that students from diverse educational background are able to emerge as versatile professionals. As shared by Kaveri, our mentor, the diversity in the batch has actually fostered peer-learning and taken the experience to next level.

 In our earlier blog, we had announced that our C-CAP batches were ready to be hired by the market. Thanks to the capability shown by our students, we have been able to clock 100% placement record for the first two batches – one from Pune and the other from our Hyderabad facility.  The students from Pune batch have been placed with reputed CROs such as TCS, Accenture and Inventive. This has once again established the viability of our systematic approach towards talent development.

Previously there was a myth that one must be statistics background to have a successful career in this industry; but with the grand success of our students it has been proved that the statistical knowledge provided in C-CAP is helpful in cracking the rigorous recruitment processes of MNCs irrespective of the student’s background. 

Watch some of our participants share their experiences with C-CAP.

         

The graduates were quite enthusiastic to share their experiences from their stint with the corporate world. Here are some of the useful insights from the interaction: 

1.     An appreciation of statistics helps a lot in cracking the rigorous recruitment process followed by MNCs for clinical programmers

2.     A sound knowledge of the domain is inevitable to navigate confidently through your job responsibilities in Clinical Trial Services Industry

3.     The exhaustive sessions on the safety domains – a unique offering as part of C-CAP, gives you an edge over your peers – both during recruitment process as well as on the job

The graduates were quite satisfied with the training provided on various classes under Safety domains - such as general observational class, special purpose class etc. One of our students shared that in his new project he is working on the assignments pretty similar to what he had worked on as part of practical training in C-CAP. Naturally this gave him an added advantage in terms of understanding of data and analysis of the same. As part of the operations team, it was very gratifying for us all to hear the kind words from the batch. The batch remains special in our heart, since they put their faith in us and gave 100% commitment as we walked along the journey.

Congratulations to all our gems that are ready to adorn the teams of these reputed organizations! We have no doubt that you will keep up the learning spirit and build an exemplary professional reputation. All the best!!

About the author – Nikhita Pemgirikar-Pasalkar, a post graduate in healthcare management , is working with CliPLab as a program coordinator in Clinical SAS Programming. She has been a key contributor in design and execution of C-CAP program.

C-CAP Xpress – Same Great Program, Now in a Convenient Pack!

We have no doubt that C-CAP has become a preferred option for graduates aspiring to enter the Clinical Trial Services Industry. With over 70 enrollments in 18 months and 100% placement record for first two batches, C-CAP is here to stay and make a meaningful contribution to the lives of many young aspirants.

The success of C-CAP can be attributed to its thoughtful design and meticulous execution.  The format of the program was designed after a series of brainstorming sessions with programmers, leads and managers working in the industry.  Through such discussions, we identified the skills and exposure areas that have a direct and significant bearing on the productivity and performance in Clinical Trial Analytics projects. Next, we invited experienced professionals in the industry to design and develop the training modules. Further, the sessions are facilitated by professionals who themselves are working in various roles on live projects.

Some of the key competency areas that we have identified and addressed through C-CAP are described in the coming :

1. Clinical Trial Domain Overview: Clinical SAS Programming is not merely writing program to analyze data, it is more about understanding the context and applying intelligence to select the approach for analysis. Intelligence comes from knowledge of the domain. Therefore Domain Overview becomes indispensable for anyone aspiring to succeed in the industry.  
2. Statistics Appreciation: Statistics provides scientific models for analyzing the data to extract reliable conclusions that form the basis of business decisions.  Knowledge and awareness of basic concepts in Statistics is useful even for programmers. It enables them to understand the ‘why’ in the data analysis and be able to interpret the results. The module has been designed keeping in mind that the majority of the participants may not have studied statistics at graduate or post-graduate level.
3. Therapeutic Area – Oncology:  Another factor that can help one leapfrog her/his career in this field is the knowledge of the therapeutic area corresponding to the study project. We have picked Oncology which is one of the most extensively studied therapeutic area. Oncology is also peculiar when it comes to treatment of endpoints.  A training module on this topic delivered by a veteran can definitely give the candidates an edge over others trying to get on to a project in Oncology.  We are also planning to add courses on a few other therapeutic areas in future.
4. CDISC Standards: The CDISC open data standards have been developed collaboratively by global volunteers to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting. The standards facilitate transfer of data and information in Clinical Research across the organization.  As the standards are adopted / being adopted by most of the global pharmaceutical companies,  it is imperative to have practical knowledge of these standards. As part of C-CAP, we have developed theory and practical training in two of the CDISC standards – SDTM and ADaM.
5. Practical Assignments: Apart from studying the topics explained above, the participants also get a chance to work on a set of assignments in data analysis and validation using SAS^®. The intent is to give the participants a flavor of the modular tasks that they will be asked to undertake at their first job.  The assignments are conducted in a simulated environment that goes closest to the actual project situation.

The stupendous success of C-CAP has inspired us to work further to build a model that will benefit an even wider group of aspirants. Yes, we have bundled the best of C-CAP and packaged it in a convenient format so that you can upgrade your skills without leaving your town. The program, named as C-CAP Xpress aims at providing the candidates with knowledge of essential topics and relevant practical training in the field.  In this guided program, the theoretical sessions are delivered through online learning, while the practical assignments can be taken by accessing our server remotely. Besides, the candidate has access to several clarification sessions with our experienced faculty members. The tentative course structure is as below.

eLearning sessions will be available through our eLearning portal – lms.cliplab.co.in

Apart from the aspiration to make a career in Clinical Programming, Proficiency in SAS Programming language is another pre-requisite to enroll to C-CAP Xpress. Getting the vital skills to foray into Clinical SAS programming has never been so easy. We hope this latest offering will enable us to help some more aspirants fulfill their dream of a thrilling career.  You are invited to visit the page on the our website to know more about the program.     

C-CAP...The vital step towards a brighter future !

Youngsters aspiring to enter any career stream of their choice often complain that every recruiter demands certain amount of experience. They find themselves confused about where to get the work experience from, in a highly regulated industry such as Clinical Research.

With highly critical and responsible tasks to do, the industry faces lot of regulations. Timelines drive this industry. Considering the nature of work it is obvious why we cannot deploy freshers for such real time critical projects. Consequently, given the time it takes for anyone to develop a sizable work experience, there is no doubt that the industry is struggling with the wide demand supply gap and Cytel is no exception. This perpetual problem has forced us at CliPLab to go beyond tactical measures such as lateral hiring and think of something strategic and sustainable.

 There are many graduates aspiring to enter the Clinical SAS  programming industry today. However, they are unable to do so very easily due to lack of domain knowledge, exposure to basic Statistics, awareness of CDISC standards or sometimes the professional skills. Having been part of the team that has designed and executed the program, I can say that, C-CAP candidates are equipped with most of these vital skills and competencies and are ready to hit the ground running.

Training the C-CAP participants has been an enriching experience. I have found C-CAP participants more mature, more receptive to the training, keen observers, eager to dive deeper into the topics and determined enough to stay focused on challenging tasks. Every batch is a close-knit group and has developed a better ability to work in teams. Since the participants often come from different academic streams, I have seen a healthy exchange of knowledge and ideas and this has resulted into a better peer-learning quotient for the entire group. The unusual queries and problems posed by the participants have been inspiring and gratifying for me as a trainer.


About the Author - Dr Kaveri Gavade, previously a medical practitioner, is working with CliPLab as a trainer in Clinical SAS Programming. She has been a key contributor in design and execution of C-CAP program.

Unveiled - A short eLearning course on Oncology in Clinical Trials

Oncology is defined as a medical specialty focusing on the study, diagnosis and treatment of cancer which can affect people of all ages.  Oncology is one of the largest and most extensively studied therapeutic areas in clinical research.  A tremendous amount of research (especially in the past decade) conducted on all aspects of oncology including cell biology, radiation therapy, chemotherapy, targeted therapies and supportive care has dramatically changed our understanding of the disease.  Oncology literature is very vast (to say the least); therefore, a basic understanding of the key concepts and terminology pertaining to oncology is critical to a successful career in clinical research.

Clinical Trials in Oncology are somewhat more complicated than other therapeutic areas, with Clinical Endpoint and Adverse Event Reporting being some of the major differentiators.  This is another reason why it becomes important for professionals working on Oncology trials to develop a solid understanding of the therapeutic area. 

While working with CliPLab, as a mentor for C-CAP participants, I realized that there is a large pool of professionals that can benefit from an orientation course in Oncology and other therapeutic areas.  The work in Clinical Trial Services is not just about effective usage of analytical tools such as SAS.  Rather, it is much more about applying the knowledge of the domain to determine the right procedure, approach and the tools to be used for the analysis.  A crisp orientation course on relevant therapeutic areas therefore becomes crucial in order to expect a high level of performance from professionals working on a project in a specific area. With the intent to help working professionals develop a basic understanding of the domain, a short course titled ‘Oncology in Clinical Trials’ has been launched.   

This applied course in oncology will cover several topics from the perspective of conducting, analyzing and interpreting clinical oncology research.  The course is divided into several modules delivered in a logical sequence starting with the introduction to the disease followed by cancer risk factors, cancer diagnosis and staging, basics of cancer treatment, clinical endpoints in cancer, RECIST guidelines and clinical trial designs.  Numerous examples and illustrations are provided throughout the course to facilitate a better understanding of the underlying concepts.  This course offers an ideal platform for candidates seeking to enter a project in Oncology and can be taken at their own convenience through the eLearning portal of CliPLab. Want one more reason? As an inaugural offer, CliPLab is offering 50% discount on the course fee.

Watch for a brief overview of the course content.

Any feedback towards betterment of the course are absolutely welcome.

About the author - The author is a veteran in clinical research with over 15 years of rich and diverse experience in the field.  He has worked extensively in Oncology research and contributed handsomely to the scientific and medical literature of international repute. His profile can be viewed at https://in.linkedin.com/pub/digant-gupta/10/689/b49.

C-CAP Lite Unveiled – Merge with the highway to a great career

At CliPLab, our mission is to help youngsters build a meaningful career in Clinical Trial Services Industry. The belief in our mission has enabled us to come up with C-CAP – a proven career development program that captures all aspects of a coveted profile in the industry. While campaigning for C-CAP, we realized that there are candidates trained in SAS programming from other institutes and still unable to make a foray in the industry. We brainstormed over this and came up with an entry path for such candidates to benefit from the C-CAP program. Now, candidates already trained in SAS elsewhere, are able to join C-CAP through an option called C-CAP Lite.

The C-CAP program spans 18 months, out of which first three months are reserved for training in SAS programming. Thus candidates trained in SAS can join C-CAP batch at the end of three months for a particular batch and still get the holistic experience. How do we ensure that the candidates joining through C-CAP Lite option are at par with regular C-CAP candidates in terms of proficiency in SAS? We evaluate the incoming candidates with an in-house technical test that only the candidates with sound programming skills can clear. This helps us maintain the quality at intake and help a larger audience at the same time.

The candidates trained in SAS often go for an internship program run by various institutes or CROs in order to gain practical experience and thus ease their entry into the industry. While these options are useful to some candidates, they have their own limitations, when it comes to predictability. C-CAP Lite is designed with an intention to improve the predictability in your career path and thus create a more tangible, sustainable value in the long run. In a short video, we have examined the situation of a typical candidate, trained in SAS and seeking options to debut in the industry. Watch this video to know how C-CAP Lite can help you reduce the uncertainty in your career journey.

To know more about C-CAP Lite, visit us here.