Testimonials


Boehringer Ingelheim
"Shafi Consultancy did some very complex and important data transformations for us for high profile multiple trials..."


F. Hoffmann-La Roche
"Shafi Consultancy analysed a very large and complex database for us..."


Pharma Projekthaus
"...responding to FDA questions at short notice under extremely short timelines, Shafi Consultancy has helped our client ... meet all their timelines..."


IMS Health
"Shafi Consultancy supported us with essential data transformations and analyses that ensured we met our project timelines..."

Services


Shafi Consultancy and our subsidiary Shafi Consultancy Bangladesh have been providing SAS training and SAS Expertise for more than ten years.

The key to our success is pharmaceutical industry experience, experienced staff and total commitment to our clients needs.
Read more about the wide range of SAS programming and SAS consultancy services we provide by clicking on the links below.

SAS Consultancy


SAS consultancy can be found everywhere; however, a good SAS consultancy firm has the experience to back up its decisions. We have been providing SAS consultancy support for over ten years and have been working in the Pharmaceutical Industry for over fifteen years. In our experience, an external organisation s often best placed to look at processes and standards and give an unbiased opinion on whether they are optimal or there is room for improvement.

Our experience in working with CROs, Pharmaceutical organisations and management consultancy firms means we have a wide range of experience from which we can draw our recommendations. Over the years we have advised on our clients on everything from what constitutes good programming practices and how to implement good programming practices to how to assess training needs of their staff and develop validation SOPs and guidelines. We have also advised our clients on CDISC format data to help them determine where in the reporting process this should be implemented and how.

Our SAS consultancy services do not stop at just advising the clients on the best approaches towards solving their issues, we also provide solutions in the form of generic macros and template programs. When developing the appropriate solutions it is vital to take into account the experience and skill set of those who will use these programs. Our solutions are always provided such that they are easy to maintain and re-used again in the future, thus helping to reduce the cost and time of future studies.

See how our SAS consultancy can be of benefit to your organisation.

SAS training


SAS training is a very personal need, and every user has a slightly different need. It is also very important to learn how to think about programming, not just the syntax.

Our training modules for beginners and intermediate users are designed with this in mind.
  • Data step functions
  • SAS Procedures
    • SQL
    • Transpose
    • Means, Freq, Univariate
    • Report
    • Tabulate
  • Datasets Macros.


We can also assess the standard of SAS programming of an individual or a group then discuss the weaknesses and provide a tailor made training program.

SAS validation


Our team of experienced SAS programmers armed with our internal generic macros means we can validate tables, figures and listings using double programming very quickly.

We have provided this service to meet timelines for regulatory questions as well as part of the standard QC process of our clients.

We can also assess the standard of SAS programming of an individual or a group then discuss the weaknesses and provide a tailor made training program.

We also validate CDISC format data produced by the client, or validate tables produced from CDISC format data. Where tables were produced prior to CDISC transformation, we can produce CDISC standard datasets and reproduce the tables to ensure the results do not change.

In addition to data specific programming, we can also validate generic macros written by our clients. We develop test cases, expected outcomes and perform the time consuming task of testing all the agreed combinations to ensure the macro is robust and validated for all our clients' needs.

SAS programming support


SAS programming support can be provided to meet an urgent regulatory or submission timelines, or it can be thought of as additional resource for our clients.

We have provided support in the past for the following:
  • Programming statistical analysis datasets, tables, figures and listing
  • Programming for ISS
  • Report using CDISC format data
  • Provide check programs for data cleaning
  • Provide template programs
  • Provide generic macros


In addition to actual programming, we can also look at different processes performed by our clients and assess whether there is scope for improvement and efficiency savings. Often it takes an external set of eyes to question long established processes. We are ideally placed to perform this task based on our background in the range of clients and studies we have consulted for in the past.

CDISC format data


CDISC format data is here to stay, and in the very near future all pharmaceutical organisations will need to produce CDISC format data for all submissions. Those who prepare early have the option of looking at all their processes and trying to determine where within their process the CDISC format data fits in best. If however this is left until the absolutely required, then it could lead to delay in submission due to the time and effort required to convert legacy data to CDISC format data.

Many organisations are developing their own version of SDTM+ structure from which they will produce all their tables and listings. Although the ADaM structure is not yet stable, this too is now widely used. We have experience in both producing CDISC format data and reporting from CDISC format data. Our standard macros are designed to work with CDISC format data to speed up the reporting process, both to produce tables, listings and figures, and to validate them.

The key activity in the CDISC format data process is getting started. The longer this is ignored the more difficult it will be to implement in the future. Legacy trials which will be used in submissions will also be required to have all their data transformed into CDISC format data. This in itself is a very time consuming task, and one which must be done painstakingly and validated by reproducing all the key tables from the original trial to ensure there are no differences. We have the resources available to help our clients meet this need and advise them on the best course of action. The only certainty here is that "no action" is no longer an option.

We feel that it is in the interest of our clients to start working with CDISC format data as soon as possible. SDTM has been standard for a long time now, and developing a process to clarify how this will be created and used will ensure the tools required can start to be developed. This is the biggest reporting issue in the pharmaceutical industry at the moment, and we hope that we can help your organisation to ride the crest of this wave with confidence.

NONMEM and WinNonLin


Using SAS to produce NONMEM and WinNonLin ready datasets for Population PK/PD reporting is one of our speciality.

We work together with our clients to develop generic dataset specifications which can be re-used easily for future studies. We then develop macros and template programs which can be used in multiple studies with only minor changes in the code.

Our SAS programs are always developed with data checks to ensure that all relevant data issues are identified and reported. This helps to clean the data and ensure the final dataset we provide is fit for Population PK/PD reports. These additional listings and summary tables where required also make it easier for the Pharmacokineticist to write their report.

Web application support


In addition to SAS programming support we also provide Web application support. In an international organisation Web tools can often make many tasks consistent and very cost effective. The cost efficiencies in large mage trials and registry studies alone can run into hundreds of thousands of pounds.

There are a wide range of areas where web applications can bring efficiency where our clients did not consider such an approach in the past.

We look at process with our clients to identify where the use of web applications will bring extensive benefits. We then develop and maintain these secure tools in our clients' environment.