Operational services

Operational services includes; our expert solutions ranging from biostatistical programming, clinical study data management, clinical and regulatory writing, clinical trials disclosures to pharmacovigilance.

CRC Pharma’s biostatistics and statistical programming team provides world-class, regulatory compliant and integrated solutions, through our relevant expertise of programming and extensive experience of statistics. A right analysis of the right data, using right methods leads to right conclusions for any clinical study which would have translational impact on getting safe medicines to the public. Hence, we believe in providing scientific and rational solutions through operational support as well as strategic advice. We have capabilities to extrapolate our resources to meet the peak demands and provide dedicated teams. Our experts work with science driven and passionate clients in a team based fashion to provide applicable and reliable solutions. We work with them to determine appropriate methods for collecting, analyzing and presenting data while maintaining high compliance with regulatory guidelines and current practices in the industry. Our expertise spans across the translational spectrum ranging from preclinical to early and late phase clinical development.

Our programmers create study specific, need based, customized outputs with their adaptability to accustom to the clients specific requirements. We achieve this systematic statistical data analysis with careful, factual planning considering all the potential fluctuations in the real life scenario. Our team members are intricately involved throughout the lifespan of a project.

We provide following services:

Complete bio statistical services that include producing statistical analysis plans, performing statistical analysis, generating tables, listings and figures for the following types of drug research and development activities:

Non-clinical and Clinical Trial Design

  • Power and sample size calculations
  • Statistical review of protocol and CRF
  • Statistical sections of the protocol
  • Statistical analysis plans
  • Study output production
  • Production of statistical report

Clinical study randomization support

  • Production of randomization schedule
  • Act as an Independent Randomization Center (IRC)

Analysis, Reporting, and Publications

  • ISS/ISE Planning (clinical modules), analyses and electronic submission
  • Patient profiles and ad-hoc reports
  • Statistical Reports (CSR, Manuscripts, IB)
  • Development of CDISC compliant datasets
  • TLF creation, In-text table and appendix

DMC (Data Monitoring Committee)

  • Oversight of all aspects of development of IDMC (Independent Data Monitoring Committee) charters and statistical analysis plans
  • Data analysis and preparation of IDMC reports, including safety analysis and interim efficacy results
  • Presentation of analysis results by statisticians, who are voting or non-voting IDMC members
  • Provision of support for the coordination and execution of IDMC meetings, including maintaining meeting minutes of open and closed sessions

Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standards are highly desirable by various regulatory authorities worldwide, including US-FDA.

CRC has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider (Gold Member). We have converted more than 100+ studies (ANDA, NDA) as part of regulatory submissions, all of which have been accepted by the FDA.

We have an in house team of expert with strong technical understanding of both Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), corresponding implementation and Reviewers’ guides, CDISC terminologies and the related regulations.

Clinical programming services include statistical programming, summary and statistical reports for non-clinical and clinical studies, including:

  • Study analysis and reporting
  • Prepare statistical analysis plan (SAP)
  • Prepare analysis dataset specifications
  • Generate analysis datasets and/or ADaM datasets
  • SCS/SCE (pooling) database preparation
  • SCS/SCE (pooling) statistical analysis
  • Tables, Listings and Figures (TLF)
  • CDISC SDTM,SEND and ADaM data conversion
  • Creation of CDISC documentation ( Reviewer’s guide; Define.xml)
  • SAS programming for interim and final analysis
  • Interim analysis and DMC Support
  • Patient profiles and ad-hoc reports
  • PK/PD model development and analysis
  • Perform SAS programming verification and validation
  • Provide all programming documentation
  • Ad hoc or exploratory programming

Clinical programming services include statistical programming, summary and statistical reports for non-clinical and clinical studies, including:

  • Project management
  • On- site and off-site CDM services
  • Data management plan (DMP) development
  • Paper CRF/eCRF design and development
  • Query tracking and query management
  • Medical coding for medical history and adverse events (ADR/AE)
  • Safety data management & reconciliation
  • Laboratory data reconciliation
  • Data export/transfer
  • CRF completion guidelines
  • CRF annotation & review
  • Database build & design
  • Data validation specifications
  • Edit checks, programming & testing
  • Data processing through double data entry

We provide complete and comprehensive clinical data management solutions from study start through clinical database lock for all clinical study phases i.e. Phase I to Phase IV, with both for FSP Model as well as stand-alone projects. Our Clinical Data Management (CDM) team extends its best practices from across our existing capabilities of statistical software products and services.

We support this, by using best-in-class technology, with 21CFR compliant tools, to provide time based, reliable and reproducible results to our small and mid-size Pharmaceutical and Biotechnology companies across the globe.

It is the moral and scientific responsibility of all the stakeholders (patients, caregivers, healthcare providers, payers and regulators) involved in the conduct of clinical trials to honor the significant contributions of the clinical trial participants. One of the primary objectives of clinical trial research is to ensure the safety and well-being of the study participants, with a broader implication on sharing trial results to advance the field of medicine. Despite increasing public and regulatory pressure including a legal mandate to disclose clinical trials results, the compliance rate is still low. Some of the key reasons for this low compliance could be lack of awareness among academia, industry and journal editors of the legal responsibility to disclose clinical data, inadequate resources, funds, lack of enforcement etc.

We at CRC Pharma, provide services, technology, and expertise to meet evolving transparency and disclosure requirements by the sponsors. Our team is highly qualified and experienced in clinical trials development and implementation across various therapeutic areas. They, thus, have impeccable capabilities to provide reliable solution for clinical trials disclosures.

Some of our members are also contributing as editorial experts to review lay language summaries with one of the most admired and respected non-profit organization engaged in recognizing public and patients as partners in the clinical research process.

We work with our clients to satisfy their needs as per regulations in US (FDA, NIH) and Europe such as the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing, European Union Clinical Trials Regulation, EMA policy (0070) for data transparency amongst others.

Key services are :

  • Anonymized clinical documents (prospective and retrospective clinical data)
  • Individual patient data anonymization
  • Writing simple, easy to understand clinical lay language summaries (CLLS)
  • Review of the CLSS, to authenticate its compliance with the regulations
  • CSR redaction (with more focus on redaction PPD, CCI )
  • Supports clinical protocol registrations and disclosure of study results

In any drug development program for any therapeutic area two important milestones are critical, one, interaction with the regulatory authorities and second, dissemination of the outcome of the clinical development program to the research community and the public at large. This involved a dedicated sustained efforts and research, infused with millions of dollars investment. Hence, it is utmost important to create, review and finalize these regulatory submission documents (e.g. NDA, BLA, ANDA, CSR, IB, protocol etc.) under an expert review and care. It is also a critical step to prepare these reports/documents with scientific rigor, methodological detail and all of the information necessary to support a clear interpretation of the analysis and conclusions.

Our team have an extensive experience of working in drug discovery, non-clinical, formulation and clinical development programs with a concrete understanding of the regulatory landscape. This unique exposure help our translational clinical pharmacologist to connect the scientific dots efficiently and with a translational science approach to do a scientific and regulatory justice to the product under study.

Key service are :

  • Pre-IND, NDA, BLA authorship, compilation, correspondence and submission to US-FDA
  • ANDA, 505(b)(ii) authorship, compilation, correspondence and submission to US-FDA
  • Writing the clinical modules as per CTD
  • Writing high scientific quality clinical study protocol, IB, CSR, PIS etc.
  • Consult to the sponsors on planning non-clinical and clinical development plans

Health Economics and Outcomes Research (HEOR)

  • Global Values Dossiers (GVDs), including AMCP-guideline-based GVDs
  • Retrospective and prospective observational studies
  • Retrospective chart review analysis
  • QOL based studies, planning, analysis and writing
  • Structured literature review (SLR)

Medical Writing

Our highly motivated and educated (Ph.D.’s, MS) medical writers include members of the American Medical Writers Association (AMWA) and members as well as Fellow of the American College of Clinical Pharmacology, (ACCP), who have greatly benefited from the highly specialized training from these professional organizations. Our team works with the “Team Science” spirit with a translational research approach. This dynamic team writes and edits broad spectrum of documentation, for internal and external company/client use, regulatory submissions, publication or marketing support. While drafting these high quality documents we follow GPP3, ICMJE and other related guidelines based on the specificity of the writing need. Our medical writing staff have experience in the therapeutic areas of cardiovascular, dermatology, critical care, autoimmune, diabetes/endocrine, neuroscience, oncology and infectious diseases. All the scientific documents produced by our medical writing team are thoroughly reviewed and undergo complete QC during editorial review before submission to the client.

Key services are:

  • Publication planning, implementation
  • Original research manuscripts
  • Letter to the Editor
  • Review manuscript
  • Systematic review
  • Meta- analysis
  • Congress abstracts, posters, and oral presentations
  • End to end submission to the scientific journals
  • Review of the scientific manuscripts
  • Newsletters, congress reports, and sponsored journals
  • Slide decks, narrative reviews

CRC have highly skilled and experienced clinical pharmacology group for the analysis, modeling and interpretation of PK/PD data. We also provide assessment of clinical relevance and insight into results for use in drug research and development decisions for clients. Our experts bring the experience of drug labeling, integration of populations PK/PD studies into clinical studies to obtain useful safety, efficacy and dosage optimization information to impact drug labeling.

Key service are :

  • Expert PK input to preclinical and clinical development plans
  • Study design with sample size calculation, optimized sampling schedule
  • Derive PK parameters using Phoenix®, WinNonlin® / R as a standalone service
  • Non-compartmental PK/PD analyses
  • Compartmental PK and PK/PD modeling
  • Population PK/PD modeling
  • Standard Bioequivalence (BE) and Bioavailability(BA) assessment (including food effect)
  • Drug-Drug Interaction (DDI) assessment
  • PK/PD Analysis – modeling the relationship between exposure and response using nonlinear models and nonlinear mixed effect modeling.
  • Toxicokinetic Data Analysis – For GLP toxicology studies, we perform model
  • independent (non-compartmental) analysis to establish exposure, accumulation, and linearity of absorption

Consulting

Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your PK/PD focused programs. CRC Pharma can help design appropriate pharmacokinetic studies, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.

We at CRC Pharma firmly believe that “Medicines heal, but can also harm” and hence we also provide our clients with services to tackle the challenges related to drug safety i.e. Pharmacovigilance (PV).

We offer complete pharmacovigilance services from Phase I to post approval Phase IV studies. Our PV services includes Initial intake of adverse events from spontaneous sources and process them within safety database according to the ICH guidelines. We also provides medical communication services to answer any product related questions and also able to handle product quality issues and reimbursement requests as needed as per the client specifications. We conduct appropriate follow-ups with consumers and HCP’s in order to obtain complete clinical information pertinent to single case for its completeness. We also generate safety queries for clinical trial SAE reporting and follow-up with study investigators for completeness of the case.

Key services are :

  • Serious adverse event (SAE) case processing of initial/follow-up reports
  • Generation of case narratives, MedDRA coding, WHO-DD coding
  • Responsible point for EudraVigilance
  • Safety Data Management & Global Safety Database – Oracle Argus, ARISg and agXchange
  • Signal detection integrity & evaluation by using EMPIRICA
  • Development Safety Update Report (DSUR), periodic safety update review (PSUR) preparation and submission
  • Pharmacovigilance Quality Assurance including SOP development
  • Reconciliation of Serious Adverse Events for all studies and patient assistance programs
  • Benefit and risk evaluation & risk minimization plan (RMP) and strategies
  • Study documentation review and update, including protocol and IB