Success Stories / Selected projects

Content Management/Enterprise NDA Submission Architectures

  • For several pharmaceutical majors, designed, developed and commissioned custom Documentum™ distributed eContent server between North America and Europe. Integrated with publishing systems, custom object model and taxonomy the architecture is scalable for Asia-Pacific access. The commissioning was also followed by administrative support and product migrations.
  • For a pharmaceutical major, architected and developed an enterprise-wide API-service based configuration layer for use by external content submission systems to facilitate deposit of submission content to a central repository using a validated, repeatable approach


  • For several pharmaceutical majors, performed distributed/non-distributed Documentum eContent server installations (6.x) and integrated with products such as FirstDocTM and DCMTM using BEA Weblogic/supported Web servers and Oracle on Solaris/UNIX platforms. Also integrated publishing systems with eContent Servers
  • For pharmaceutical majors, enabled Documentum and custom Web-portal application access via CITRIX servers

Performance enhancements

  • For a number of pharmaceutical majors, evaluated Documentum and custom Web-portal Client/Server performance limitations and proposed solutions after a rigorous metrics gathering exercise over the LAN/WAN. Implemented custom object model and infrastructure component enhancements for third-party products such as FirstDocsTM using BEA Weblogic and Oracle on Solaris/HP-UX platforms


  • Provided technical lead services for a pharmaceutical major to enable systematic and controlled FDA submissions migration for facilitating their merger with another pharmaceutical major. Working with the business leads, migrated and merged target and source object model and submission data, preserving audit trail entries and required business rules
  • Our team has performed several Documentum™ (distributed/non-distributed) custom server migrations spanning across 5.x and 6.x server repositories and across operating systems/database preserving or converting to new custom object model/taxonomy based on requirements (FirstDoc, D2, C6, etc.) audit trials, etc.
  • For a pharmaceutical major, facilitated using a validated approach, migration of about 1.5 terabytes of content between and within major submission docbase following established taxonomy and object model.
  • Developed and executed content migration architecture for migration into a single validated Documentum repository from different content and meta-data sources (FirstDoc, LiveLink, SharePoint, filesystems) with Oracle DB/other supported DBs.

Custom Application Development

  • Architected and developed custom Documentum 6.x-server based application with Webtop interface customizations to facilitate NDA submissions. Developed custom object model, taxonomy and user-interface components.
  • Architected and developed custom Documentum application interfaces with InputAccel scanning station for processing validated NDA submission content and attributes
  • Development support, enhancements, trouble-shooting and user-support for a pharmaceutical major for their Documentum™ 5.x Web-based WDK/DFC portal.
  • Architected and developed custom FDA submissions rendition engine design for a pharmaceutical major.

Biostatistics Workshops

  • Dr. Rajaram Lakshminarayan presented a keynote Lecture on the topic "Biostatistics: What is Biostatistics and Why Do We Need It in Biomedical Research" at The 22nd International Conference on Nutrition and Integrative Medicine held in Sapporo, Japan in July 2014 and was received very well.
  • Dr. Rajaram Lakshminarayan co-authored in the 2014 Academic College of Emergency Experts in India′s INDO-US Joint Working Group (JWG) White Paper on "Developing Trauma Sciences and Injury Care in India".
  • Dr. Rajaram Lakshminarayan, jointly with Carlos Callegari presented a workshop on the “Review of Survival Analysis Techniques to Analyze the Chronic Disease Data” at The XIII Mediterranean Conference on Medical and Biological Engineering & Computing held in Seville, Spain. September 2013.
  • Dr. Rajaram Lakshminarayan presented a talk as an invited speaker in the Special Session and Panel on "Medications and Vaccine Safety" at the XIII Mediterranean Conference on Medical and Biological Engineering & Computing, Seville, Spain. September 2013.
  • Dr. Rajaram Lakshminarayan presented a lecture as an invited speaker at the mini-symposium of "Biomedical Engineering during Disasters-Health and Crisis Management on Statistical Aspects of Social Media in Public Health" in the World Congress on Medical Physics & Biomedical Engineering in Beijing, China. May 2012.
  • Dr. Lakshminarayan Rajaram conducted a six-hour workshop to train residents, medical students and faculty in Medical Statistics as well as Advanced Protocols for Conducting Clinical Research in India at the 4TH Annual Indo-US Emergency Medicine Summit in October 2008 held at A. J. Institute of Medical Sciences, Mangalore, India.
  • Dr. Lakshminarayan Rajaram conducted a one-day workshop on "Bioavailability and Bioequivalence Trials: Statistics and Pharmacokinetic Principles" in the "International Congress on Medical and Care Compunetics (ICMCC)", held in The Hague, The Netherlands.
    The workshop focused entirely on the fundamentals of the bioavailability and bioequivalence studies. The topics that were addressed in-depth included definition of bioequivalence (BE), purpose of BE, approaches to determining BE (21 CFR 320.24), study designs, measurement and analysis of pharmacokinetic parameters, statistical analysis (two one-sided tests procedures, BE criteria, etc.), and applications of the statistical analysis software (SAS) to perform BE analysis.

Biostatistics Courses

  • Dr. Rajaram Lakshminarayan presented, as an invited speaker, a one-day tutorial on “Biostatistics” at the 7th International Council on Medical & Care Compunetics (ICMCC) Conference held at the University of Westminster, London.
  • Dr. Lakshminarayan Rajaram taught a 6-day summer course in AIIMS, New Delhi , India to a selected group of emergency medicine physicians. This course consisted of four parts: Fundamentals of Clinical Research, Clinical Database Design & Data Management, Analytical and Computer Applications in Clinical Research.
    The manifold objectives of the course were to impart skill development in clinical research study methodologies and designs, principles and designs for developing databases for epidemiological and clinical research studies, and descriptive and inferential statistical methodologies commonly used in clinical research with applications of statistical software to conduct such methodologies with examples as well as the interpretation of the results. The course also included an extensive hands-on session to practice the knowledge learned.
  • For a leading pharmaceutical company based in Bangalore, India, Dr. Rajaram conducted a workshop in Nov 2013 on Mixed Models for their Biostatisticians. The workshop included detailed case studies using clinical data.
  • For a leading pharmaceutical company based in Bangalore, India, Dr. Rajaram offered a 2-day workshop that dealt with understanding statistical techniques, the theory behind them and their application to commonly encountered clinical trial scenarios for various problem domains. This was very well received with excellent feedback from the students.

Application Support

  • Developed a dedicated support team for a major pharma for providing application support for custom Documentum 5.x applications (Webtop, custom interfaces)
  • Technical services for a pharmaceutical major in the development and production rollout of a Documentum™ workflow-based authoring, review and approval system. Involved in entire SDLC and responsible for providing validated 5.x and 4.x distributed eContent server repositories for phase-based development, testing, trouble-shooting and production rollout.

Clinical Trials Management/Statistical Analysis

  • Developed a series of SAS program templates for a contract research organization to perform complete statistical analyses of bioequivalence studies that included generating SAS datasets, tables, graphs and statistical analysis reports according to FDA submission guidelines.