- Development of study data tabulation model SDTM and ADaM datasets
- Development of SEND datasets
- Creation of tables, listings, and figures (TLF), in-text tables & appendices
- Support of clinical study report (CSR), integrated summary of safety & efficacy (ISS/ISE), interim analysis, agency filings, safety surveillance & publications
- Support of database edit checks, query creation, patient profiles & ad-hoc reports, as well as data review and monitoring tools such as SpotFire
- Support of data monitoring committee (DMC) meetings as unblinding programmers
- Support for statistical method development, simulations, sample size calculations, exploratory analysis, and research projects
- Acquire sponsor approval on SDTM aCRF, CRT Specification, Datasets and DEFINE.
- Work within sponsor systems and follow their process for version control.
- Ensure aCRF and CRT Specification are validated by an independent SDTM Lead or experienced programmer.
- Validate SDTM datasets via dual independent programming.
- Review reports from Pinnacle 21 Community SDTM datasets and Define.
- Stay up to date with the latest versions of the IG, Controlled Terminology, TAUGs.
- Develop and maintain utilities macros for repetitive tasks.
- Supporting on aggressive timelines such as PMA Analysis
Statistical Programming
Clinical Data Management
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- Certified Medidata RAVE Builders
- Access to other EDC solutions (Low Cost, Oracle etc.)
- Data Management Plan (DMP) development
- Data Management Project Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
Clinical Data Management
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- Certified Medidata RAVE Builders
- Access to other EDC solutions (Low Cost, Oracle etc.)
- Data Management Plan (DMP) development
- Data Management Project Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
Biostatistics
- Support to pre-clinical studies
- Protocol Input
- Randomization/Unblinding
- Statistical Analysis Plan (SAP) and Output Shells
- Clinical Data Interchange Standards Consortium (CDISC)
- Output Production
- Production of Statistical Report/Clinical Study Report
- Interim Analysis/Data Safety Monitoring Boards (DSMBs)
- Meta Analysis
- ISS/ISE
Quality Assurance
How we ensure quality
- Coaching by senior level programmers
- Effective resource planning*, portfolio planning and progress tracking
- Strict project timelines and consistently achieved quality targets
- Development, maintenance and adherence to portfolio/project programming standards
- Productivity and full utilization of assigned team members
- Continuous monitoring of quality and timely delivery.
Our senior level programmers periodically coach our juniors helping them grow professionally. Each week one of our employees makes a presentation on a function of SAS or any domain of SDTM or ADaM data sets.
The Standard program life-cycle starts from the creation of the program after completion of which it gets ready for Quality Control. The validator checks and compares and if everything is correct it reaches the hands of the Statistician. But if anything doesn’t comply or there are issues, it moves back and the cycle starts from the beginning.
Though this is the main life-cycle we take a flexible approach and are ready to adapt our methods according to the requirements of the client.
Normally, before the beginning of the study and during a meeting with the client we discuss the details related to the study, the resources, the timesheets, the required documents such as crf, protocol, SAP, Shell raw data and timelines. We put the date and duration of the dry run, final run, production run etc, as well. We strictly follow timelines never compromising the quality of the work.
As everything develops quickly and keeps changing, we always plan our resources in advance and track them. We know our programmers well which enables us to utilize their resources accordingly and make right assignments to them, which guarantees efficiency.
Extensive quality control (QC) with peer review twice processed (independent) production and validation programming with a Pinnacle report run on your data every time we deliver a draft. Finally, a lead statistician and senior reviewer examine all calculations and statistical outputs; ensuring you receive the highest level of precision, efficiency and data integrity. All, those points together assure the high quality of our services.
Why You Should Choose Us
Reliability
Once you give us trust, you will get confidence that we are a reliable partner that delivers the most cost-effective and quality services in the market. Who doesn’t appreciate the opportunity of paying low costs for high-quality work?
Responsibility
Our employees treat their job with a high level of responsibility and we are always ready to go the extra mile to get the work done properly and have satisfied customers. We are disciplined and always strictly follow the deadlines.
Cross-industry expertise and leadership
Our people are our greatest asset. We have highly qualified staff, English speaking professionals with 4+ years in the industry. Our team is hardworking and enthusiastic. You can use our talent to outsource. We provide unmatched services in 10+ therapeutic areas. Our dedicated programming team has in-depth knowledge and expertise in your specific therapeutic area, allowing for fast and seamless completion of tasks, delivering high-quality output every time. Coaching and mentoring are crucial for our performance growth, personal and technical development with the purpose of enhancing our capabilities. We will always go above and beyond to bring you the best talent and the best experience. We leverage our collective strengths and talents to serve our clients to the best of our abilities.
Organizational Discipline and the Best Solutions
We carry out continuous monitoring of quality and ensure timely delivery, as well as productivity and full utilization of assigned team members. The autonomy, proactivity, questioning mindset and independent programming are guiding principles for us. We fulfill effective resource planning and forecasting, portfolio planning and progress tracking to ensure project timelines and quality targets are consistently achieved.