Latest News - RPM establishes Corporate Headquarters in the Carlsbad Research Center, Carlsbad CA.
Latest News - RPM establishes Corporate Headquarters in the Carlsbad Research Center, Carlsbad CA.
Latest News - RPM Mumbai acquires office space in the landmark Boomerang green building, Andheri (E), Mumbai.

RPM Alliance provides reliable, high quality clinical research and data management services to biotech and pharmaceutical companies, as well as contract research organizations.

As a U.S. company with operations in India, RPM is uniquely able to offer the advantages of diverse patient populations and an expansive talent pool, as well as rapid turnaround, great cost efficiencies and true flexibility, without sacrificing quality. We tailor our work to the individual specifications and scale of each project, while our knowledgeable and forward-thinking leadership in both clinical and analytical capacities sets us apart as a niche contract research organization that can be trusted as your partner in clinical excellence.

COMPANY OVERVIEW

RPM Alliance, LLC was founded in 2006 as a boutique contract research organization with quality, reliability and cost efficiency as core tenets. We provide solutions that are customized for each client, whether pharmaceutical or biotechnology companies, or other CROs. As a U.S.-based company with operations in India, we are able to scale to project requirements while remaining nimble enough to adjust as the project unfolds, without losing sight of timelines, budget and excellence in our work – especially in the areas of patient safety and data integrity.

Strategically headquartered in La Jolla, California, and led by Harvard-trained physicians and experienced clinical technicians, RPM Alliance offers clinical research and data management services for the life sciences industry across the U.S. and India. RPM Bio-Pharma India Pvt. Ltd., our wholly owned subsidiary in Mumbai, India, provides clinical data management services and statistical programming, and serves as our base for clinical research operations in South Asia.

RPM Alliance is a stable resource within a typically fractured, unreliable sea of service providers. We invest the best of our talent and experience in our client relationships, with a goal of developing lasting partnerships with others who share our vision for quality and excellence.

VISION & MISSION

In partnership with biotech, pharmaceutical and CRO clients, RPM Alliance sets the bar for quality, efficiency and cost effectiveness in all facets of clinical research and data management. RPM Alliance brings integrity and excellence to clinical research and data management services through strict quality standards, a strong commitment to timely turnaround and outstanding cost efficiencies.

LEADERSHIP TEAM

Dr. Ritvik Mehta / Founder & CEO
Dr. Ritvik Mehta is a Harvard trained physician and surgeon. With more than sixteen years of clinical research experience, Dr. Mehta has published extensively within the field of Otolaryngology / Head and Neck Surgery. Dr. Mehta received his B.S. in Neuroscience at the University of Southern California and his M.D. from the University of California, San Diego. He completed his residency and fellowship in Otolaryngology / Head and Neck Surgery at Harvard Medical School, and has extensive experience in international health. Dr. Mehta served as Medical Director for Outcome Sciences, and brings with him an exhaustive understanding of post-approval research and quality improvement technologies for healthcare.

Dr. Preeti Mehta/President
The Company’s co-founder is Dr. Preeti Mehta, who is currently a hospitalist at the Massachusetts General Hospital, a leading teaching hospital of Harvard Medical School. Dr. Preeti Mehta received her MBBS degree from the Mahatma Gandhi Missions Medical College in Mumbai, India. She completed her residency training in Internal Medicine at Newton-Wellesley Hospital / Tufts University School of Medicine in Boston, MA. She has undergone training in the conduct of clinical trials at the Harvard School of Public Health and has coordinated a multi-center clinical trial for the evaluation of treatment of myocardial infarction. Her vast array of organizational and managerial skills in this arena bring great strength to her role as President of the Company.

Mr. Raju Chapagai, MBA, M.Sc – Executive Director / Lead Clinical Data Management
Mr. Raju Chapagai received his MBA, with DISTINCTION, from Bharathiar University and Master of Science in Biotechnology from Bangalore University. Mr. Chapagai has extensive experience in Clinical Trial, Clinical Data Management, Biostatistics, Medical Writing, Pharmacovigilance and Quality Management that includes Clinical Programming, SAS Programming (CDISC, SDTM, ADaM, TLF, SAP, etc), Database design Programming (Medidata Rave, Medrio, Merge, Inform, Oracle Clinical, ClinCapture, OpenClinica, REDCap Cloud, Quintiles Infosario, etc), Mapping Specifications, Clinical Coding, System Integration and Migration, DMP, Lab Data Reconciliations, Statistical Analysis, SAE Reconciliation, Protocol Writing, Clinical study report (CSR) Writing, Clinical Audit, etc. His experience as Process Analyst, Certified Data Validation Associate, Project Lead, Lead Clinical Data Manager and Country Manager provides a combination of end-to-end Data management, Medical Writing and Biostatistics solutions. Expertise in development and maintaining an efficient business oriented Contract Research Organization (CRO); Business development (Request for proposal & Bid defense), Client Relations, Operations Management, Project management and Human Resource management supporting some of the top fortune 500 companies. Prior to his association with RPM, he worked with Accenture.

THE RPM ADVANTAGE

RPM Alliance was founded on core precepts that provide an unequivocal advantage to our clients.

QUALITY

We value quality in our work above all. It’s a priority that impacts every facet of our work, from global standards to safety matters, from time efficiency to communication with clients, and everything in between.

EXPERIENCE

The management team at RPM Alliance brings over 35 years of combined experience in clinical trial and data management services, which means you can depend on us to be a knowledgeable resource as well as a reliable service provider as your project unfolds.

TIMELINESS

We pride ourselves on our consistently rapid turnaround, a quality that is often refreshing to clients who have seen delays due to the slow pace of work that seems to be the norm for many CROs.

RELIABILITY & ACCOUNTABILITY

We have built a strong infrastructure for ongoing efficiency and continue to carefully develop a quality workforce. As our client, that means you can trust us to be here for the next phase of your project, and for every future venture – your steady partner in clinical excellence.

COST EFFECTIVENESS

Leveraging the advantages of offices and staff in both the U.S. and India, we are able to leverage work forces across time zones to provide our clients with significant savings as compared to our competitors, without sacrificing quality or timeliness.

INTEGRITY & RESPONSIVENESS

When we commit to a specific standard, timetable or budget, we do what we say we will do; and since we believe that good communication is key to project success, we make a priority of keeping our clients informed.

PERSONABLENESS

We enjoy what we do, and it shows.

EXPERTS IN ACCURACY
AND SECURITY

COMPLETE DATA MANAGEMENT SERVICES

Your data is clearly your most valuable asset. RPM Alliance is your resource for complete and dedicated clinical data management. In the increasingly global arena of clinical drug development, data often streams in from a multitude of partners from various regions of the world. RPM provides centralized data management that ensures uniformity in acquisition, cleaning, and coding of your data – regardless of where it was acquired.

Case Study - Coding Experts

RPM manages more than 30 studies actively for coding of medications (WHO Drug coding) and adverse events (MedDRA dictionary) at any given time. We have dedicated coding experts for first and second pass coding to ensure maximum quality and adherence to coding conventions and guidelines.

Case Study - RPM Reduces Database Build Time

RPM developed solid in-house expertise on a major CRO client’s Electronic Data Capture (EDC)/database system and has implemented a streamlined, methodical approach to database build with specifications and edit checks. RPM is now part of the database build process for the vast majority of our clients’ studies with turnaround times of less than 5 days for most studies. RPM has allowed the client to significantly shorten their database build time from the time of CRF finalization. RPM recently was asked to help with database build for a major European regulatory agency project with a 300 page CRF and >11,000 edit checks and form controls. RPM reduced our client’s build time from a traditional 6-8 weeks to less than 3 weeks to meet their tight regulatory timelines.

Medical Device Study - Data Entry Audit

RPM was asked to assist with a large data entry audit requested by a client for a long term outcomes study for a surgical medical device. The study involved data entry from paper CRFs and RPM was asked to conduct a thorough review of the original data source and compare it to the database entries. RPM was able to complete the requested audit of thousands of forms within a short 6 week period, meeting the client’s deadlines and expectations.

Case Study - Database Migration

RPM was asked to assist with migration of data from a legacy database to a new client database. Unfortunately, information from the old database had to be extracted manually as the third party who created it did not have a way to export certain text information. RPM was able to recover all the necessary information from the legacy database with rapid turnover and further assist with building of the new database with up to date specifications and edit checks. RPM met all deadlines associated with migration and addressed backlog issues with coding to allow the client to successfully utilize all data in time for an urgent data cut.

DATA ENTRY

Our meticulously trained data entry personnel use double data-entry for paper-based studies. We also provide data entry services to healthcare organizations transitioning from paper-based records to electronic records.

CHART ABSTRACTION / DATA COLLECTION

Our data collection / chart abstraction teams access appropriate records per study protocol and enter data according to rigorous standards. Double data entry, if feasible, is utilized to ensure highly accurate data.

STATISTICAL ANALYSIS

RPM Alliance SAS certified programmers provide statistical programming of listings, tables and graphs, backed by quality control practices that ensure data quality at all stages of statistical programming and data analysis.

CASE REPORT FORM

Our team has extensive experience in creating annotated CRFs in accordance with protocol requirements, client specifications and CDISC standards. Our experience in the entire life cycle of clinical data management, from CRF creation to database locking, translates to expedited timelines.

COMPLETE ECRF DESIGN / DATA VALIDATION / FORM CONTROLS

Once the study protocol and annotated CRF's are finalized in conjunction with the client, our team provides complete eCRF design services, including electronic data validation checks and form controls to maximize data quality. Our clinically oriented team provides the highest levels of data validation checks, balanced with protocol and study-specific requirements to avoid excessive burden on sites.

DATA MANAGEMENT PLANS

Our medical writers and clinical data managers work together to create a detailed Data Management Plan for every project. We outline study specifics per client requirements, as well as a detailed overview of data quality and cleaning procedures to be utilized.

MANUAL REVIEW / DATA CLEANING

At study launch, manual review and data cleaning procedures are carefully outlined in conjunction with client requirements. Our team performs scheduled concurrent review of data, including trend analysis to yield the best possible data quality.

QUERY MANAGEMENT

Query management is a carefully monitored process at RPM Alliance. Performance metrics related to query management are tracked routinely and analyzed periodically to ensure data management quality standards.

MEDICAL CODING

MedDRA coding for adverse events and WHODrug coding for medications is utilized per client specifications. Our extensive experience in coding with a clinically-oriented data management team provides our clients with rapid, efficient, high quality coding. Performance metrics for coding, including both quantitative and qualitative metrics, are routinely employed.

SAS PROGRAMMING

Clinical data integration with SAS ensures standard, trusted clinical data. We increase efficiency by automating repeatable clinical data integration tasks. Our SAS certified programming team ensures a decrease in FDA submission timelines by improving the process of getting data ready for statistical analysis, increasing accuracy through electronic data quality control, embedding industry-standard data models (CDISC) into the analysis system, optimizing auditability and traceability, accelerating data access, and integrating and leveraging powerful SAS statistical and reporting tools.

SERIOUS ADVERSE EVENT / REPORTING RECONCILIATION

As part of our pharmacovigilance service offering, we offer SAE reporting and reconciliation services, as well as regulatory reporting, medical writing / safety narratives, trend analysis, and risk management plans.

ELECTRONIC DATA CAPTURE (EDC) BUILD CONSULTATION

The RPM EDC build consultation is a critical step that ensures high quality data output. Able to work with a wide variety of EDC systems, our team provides consulting during the EDC build phase to ensure that the study is built correctly, with appropriate form controls and edit checks, in order to minimize data issues later.

DATABASE LOCK / DATA TRANSFER

Datasets are prepared and transferred to the sponsor at specified time intervals. We perform all data management activities in conjunction with final database lock.

MEDICAL WRITING

RPM medical writers are available to provide:

  • Protocol development
  • Data management plan creation
  • Safety narratives
  • Study summary reports
  • Publications

THE RIGHT TALENT,
THE RIGHT PATIENTS

PHASE II - IV CLINICAL TRIAL SERVICES

RPM Alliance partners with pharmaceutical and biotechnology clients to provide sites for Phase II – IV clinical trials in India. India has been recognized as a quality emerging market for clinical trials, featuring a vast pool of treatment-naïve patients; fast recruitment of subjects; a growing reservoir of talented, GCP-trained, English speaking investigators; and significant cost savings.



PATIENT & INVESTIGATOR RECRUITMENT

RPM Alliance’s extensive network of trained investigators bring expertise in several therapeutic areas:

  • Cardiovascular disease
  • Infectious Disease / HIV
  • Oncology
  • Pulmonology
  • Neuropsychiatry
  • Diabetes / Endocrine Disorders
  • Genetic / Metabolic Disorders
  • ENT / Opthalmology
  • Rheumatology

REGULATORY AFFAIRS

RPM Alliance provides full regulatory support for clinical trial services:

  • Compilation and submission of complete dossier for DCGI submission, with all required forms and appendices
  • Obtaining of necessary Ethics Committee approvals (institutional or regional)
  • Obtaining of import license for clinical trial materials
  • Ensuring of customs clearance of clinical trial materials in Mumbai (or other port of entry) and ensure secure, cold-chain supply transportation via courier to depot facility
  • Obtaining of export licenses from DGFT if needed for export of clinical trial samples (e.g. specimen processing, etc)
  • Filing of required reports: SAE report, Annual Study Reports, End of Study summary

We partner with pharmaceutical depots that keep skilled pharmacists on site and provide world-class services for drug storage and packaging, including:

  • Temperature-controlled storage facilities (15-25 °C, 2-8 °C, -20 °C, -70 °C)
  • Inventory management
  • Returns and destruction processes
  • Primary and secondary packaging services
  • Controlled substance handling

PHARMACOVIGILANCE

RPM Alliance pharmacovigilance services include:

  • MedDRA coding
  • Adverse event management and reporting
  • Regulatory reporting
  • Medical writing / safety narratives
  • Trend analysis
  • Risk management plans

QUALITY ABOVE ALL

At RPM Alliance we can stand boldly behind the accuracy and integrity of our work, because we are nearly fanatic about quality control.

We define quality as compliance with requirements combined with credibility and reliability of the data obtained. We diligently apply strict quality management systems (QMS) to ensure, control, maintain and constantly improve quality. These systems encompass several preventive measures, tools and controls that coincide with a series of measurements, inspections and tests throughout work processes. Monthly external and internal audits assess the effectiveness of our quality control activity and give our clients the confidence they require to move their project forward.

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SAN DIEGO, CA
2390 Faraday Ave
Carlsbad, CA 92008
USA


Tel: 619-821-8190
Fax: 858-220-7477

MUMBAI, INDIA
RPM Biopharma India Pvt. Ltd.
A-104A Boomerang Building
Main Chandivali Farm Road, Near Chandivali Studio
Andheri(E), Mumbai – 400072
India


Tel: 91-22-65308008, 001-858-779-9933
Fax: 91-22-40241318