Clinical Operations

Data Management

Biostatistics

Medical Services

IWRS

Central Laboratory

Quality Assurance

Consulting
Experience


With an experience that spans over two decades, DiagnoSearch has supported hundreds of Clinical Development Programs. This includes extensive experience for trials at each phase of Clinical Development - right from Early Phase, First-in-Man and Proof of Concept Studies to Late Phase Pre-registration and Postmarketing Studies. We understand the nuances and the distinct requirements of each stage of development and our highly experienced, multi-disciplinary Team ensures that projects are delivered ‘Right the First Time’, every time.

DiagnoSearch has supported global drug development initiatives of 12 out of the top 20 biopharmaceutical corporations and several North America and Europe based biotechnology companies. This includes Clinical Operations Services in India, Asia-Pacific Region & North America and Data Management, Biostatistics, Consulting, Medical Services, Central Laboratory & IWRS Services for projects conducted on all six continents. Our rich experience and in-depth knowledge of major regulatory pathways and guidelines enables us to meet the Sponsor and regulatory expectations in terms of data quality and delivery timelines.

Being involved for most projects right from the conceptualization stage enhances our Team’s perception of the study requirements in terms of major objectives and endpoints. This, coupled with DiagnoSearch’s highly customizable, easy-to-use, homegrown 21 CFR Part 11 compliant technology platforms like Wide-Angle-Data and Risk Engine empowers us to focus adequately on all the critical elements of each project.

Our unwavering focus on quality, scientific integrity and timely delivery has been recognized by our clients, as evident in their testimonials and a very high repeat business rate.

A few of our Success Stories:

Meningitis Vaccine Project: DiagnoSearch has partnered with WHO-PATH for the complete Meningitis Vaccine Project, an initiative for the development of a meningitis vaccine for sub-Saharan Africa. The entire program spanned over 14 years from “Concept to Market” and included 15,400+ subjects with 325,000+ CRF pages. DiagnoSearch provided full service support for the program including Clinical Operations, Data Management, Biostatisics, QA Consulting (to CDC Atlanta, HPA Manchester, RKI Berlin), Central Laboratory and Pharmacovigilance. To learn more about this program, please contact us

Multinational Type 2 Diabetes Study: DiagnoSearch conducted a Phase III Type 2 Diabetes Mellitus study in South Korea, Malaysia, Thailand, the Philippines, Mexico & Russia for a Europe-based multinational pharmaceutical company. The study had a complex dose titration scheme involving 8 different dose combinations. DiagnoSearch’s involvement for all services right from Project Conceptualization through Clinical Study Report Writing was instrumental in the smooth execution of the project across geographies. To learn more about this program, please contact us.

Dual-indication Phase III Oncology Study: DiagnoSearch provided end-to-end support for a complex oncology study having two indications with different dosing regimens. In addition to achieving subject recruitment targets in record time, meticulous planning and optimal utilization of the comparator product, facilitated by DiagnoSearch’s IWRS system led to savings worth thousands of dollars for the Sponsor. To learn more about this project, please contact us.

Phase III Vaccine Study: DiagnoSearch recently completed a large Phase III Pivotal Study for a vaccine against rotavirus diarrhea. 7,500 subjects were recruited in less than one year across 6 sites. Optimal utilization of a Risk Based Monitoring approach, ably aided by technology platforms such as DiagnoSearch’s IWRS, EDC system and Safety Processing platform ensured that the study objectives were achieved in a timely, smooth and effective manner. This was the world’s first study utilizing IWRS for an “online and offline” system for randomization and drug dispensing. To learn more about this program, please contact us.

Multi-national Infectious Diseases Study: DiagnoSearch conducted a Late Phase Dentoalveolar Abscess study for a multinational pharmaceutical corporation. Over 450 subjects were recruited in a short duration across 20 sites in 4 countries in the Asia Pacific region. The results were submitted to several major regulatory bodies and the manuscript developed by DiagnoSearch was published in an international medical journal. To learn more about this project, please contact us.

Rare Indication Study (Anaplastic Thyroid Cancer): DiagnoSearch took over the India portion of a Phase II / III study in Anaplastic Thyroid Cancer (very rare incidence ~1-2% of all thyroid cancers) from another CRO on a rescue basis. In spite of starting several months after the initiation of sites across the world, DiagnoSearch was able to beat the global subject recruitment rates by a significant margin, thanks to the deployment of unique site selection and subject recruitment strategies. To learn more about this project, please contact us.

Parkinson’s Disease Study: DiagnoSearch managed the India portion of a global Phase IIa dose escalation study in patients with moderate to late stage Parkinson’s Disease. India contributed 80% to the total subject recruitment with the query rate for India being just 5.33 per 100 CRF pages as compared to the Rest of the World query rate of 18.55 per 100 CRF pages. To learn more about this project, please contact us.

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