858-263-0510
wxc_sandiegoinfo@wuxiapptec.com

Pharmapace medical and statistical professionals have a proven track record of superior leadership and success in clinical development plan and strategy that support full medical-use and commercial objectives for your clinical program.  Our close working relationship ensures that our clients’ development efforts are medically and statistically sound and meet current regulatory requirements.

Clinical Development Consulting Core Services:

  • Provide medical and statistical expertise on development programs
  • Serve as internal biometrics function to oversee other CRO’s work
  • Provide medical monitoring, safety review of clinical trial data, application of stopping rules and regulatory expertise regarding AEs/SAEs and reporting
  • Chief Medical Officer for start-up companies that lack a full-time, in-house medical department but need an experienced medical development leader
  • Design clinical study protocols
  • Data Monitoring Committee (DMC) membership, setup, and charter writing

We utilize state-of-the-art technology and metadata-driven tools for clinical and statistical programming to achieve high quality, consistency, efficiency, and cost-effectiveness. Our programmers supply datasets fully compliant with industry standards for all regulatory requirements.

The Pharmapace team of analysts have various levels of clinical experience and diverse expertise in many therapeutic areas and various indications, such as metabolic diseases (diabetes, obesity and NASH), oncology, neurosciences, insomnia, cardiovascular diseases, ophthalmics, and agitation. Each staff member has advanced degrees in scientific majors. They are all highly motivated and dedicated.

Key areas of programming provided:

  • Data strategy for regulatory submissions
  • Analyses for the FDA advisory committee meetingsIntegrated summaries of safety and efficacy for regulatory submissions
  • Global integrated database
  • Tables, figures, and listings of clinical studies
  • Database edit checks
  • SDTM data mapping and ADaM creation along with define.xml and reviewers guide document
  • CDISC compliance and validation
  • Data mining
  • Clinicaltrials.gov publishing
  • Graphic patient profile
  • Patient narratives
  • Ad-hoc data analyses and reporting
  • Annual safety reports
  • Study quality surveillance programming for risk-based study monitoring

Pharmapace has rich experience of building a global integrated database (GIDB) for a compound with drug(s) on market.  GIDB is built to standardize the data code lists, structures, and attributes with ADaM standards, to derive the analysis variables consistently, and to minimize reporting errors and inconsistencies with consistent derivation definitions and dictionaries across the clinical programs for a compound.  Once a GIDB is set up it will greatly help unlock the tremendous value of the clinical data that your company has spent a huge amount of money, resources, and effort to acquire over many years.  The main purpose of the GIDB is to support:

  • Regulatory responses and submissions with fast turnaround to lead to approval in the shortest time
  • Manuscripts and conferences abstracts and presentations
  • Marketing promotion materials
  • Analyses for payers to secure insurance reimbursement
  • Annual safety updates and investigator’s brochure updates
  • Pharmacovigilance and safety surveillance to maintain the ability to respond to emerging safety questions that will invariably come from external medical researchers and practitioners.
  • Product life cycle planning
  • Meta-analyses to understand competitive positions for efficacy
  • Exploratory analyses to generate hypotheses for future trials or help optimize designs and identify populations of future trials
  • Data mining, including signal detection

Although building a GIDB tends to require major investment upfront, it will save significant amount of time and cost down the road for the clinical programs and commercialization.  It will become a significant asset of the sponsor.  In particular, it will allow the sponsor to rapidly address regulatory agency’s urgent requests in a timely matter.  Even a potential saving of a few days toward drug approval will almost certainly recoup the upfront investment given the revenue potential of many drug candidates.

CDISC (SEND, CDASH, SDTM, & ADaM)

The U.S. Food and Drug Administration required that sponsors submit preclinical study and clinical trial data using CDISC data standards to expedite the regulatory review cycle since December 17, 2016.  Pharmapace has provided comprehensive CDISC services to many clients for more than 200 studies with CDISC compliant data packages.  To ensure the consistency and compliance with CDISC standards and to gain efficiency, Pharmapace has built a set of tools to facilitate the SEND and SDTM data mapping and conversion process, define.xml creation, and quality control.

Our services include:

  • Consulting expertise to support clients in meeting the challenges of CDISC compliance
  • Transforming legacy data to CDISC-compliant formats
  • Preparing NDAs with full submission-ready SEND, SDTM, and ADaM data packages in SAS transport v5 (.xpt) format
  • Creating define.xml and data reviewer’s guide documents for SEND, SDTM, and ADaM data packages
  • Preparing the trial summary dataset (ts.xpt) for preclinical legacy studies
  • Performing consistency checks, which are beyond Pinnacle 21 validation checks, for define.xml against aCRFs and databases
  • Designing clinical databases with the CDASH-compliant eCRFs

We are committed to supporting your company from the design of the clinical trial to study close, and ensuring the highest level of data quality. We offer robust systems that meet regulatory guidelines (FDA, EMA) and conventions, including 21 CFR Part 11 and ICH-GCP. Let the knowledgeable experts at Pharmapace guide your company through the entire data management lifecycle.

Our data managers work to ensure on-time results of your clinical trial data. Pharmapace delivers your data before critical deadlines. While we offer quick turn-around times, we never sacrifice the quality of our results.

Keys to successful on-time quality data:

  • Data Management Vendor Selection
  • Contract Negotiation
  • Vendor Management
  • Timeline Management
  • Electronic Case Report Form (eCRF) design
  • Database build in EDC system
  • EDC setup including User Acceptance Testing (UAT)
  • Data Management Plan (DMP)
  • CRF Completion Guidelines
  • Programming of Complex Edit Checks
  • Data Review and Query Management
  • Third party Data Reconciliation (Central Labs, SAE Database)​
  • Thesaurus coding management- Safety Data and Concomitant Medications
  • Database Lock and Archive

From the early stages, Pharmapace’s medical writers are involved in critical aspects of your projects and we have clinical development expertise across all phases of drug development.

Our medical writers are here to assist you in the drug development lifecycle across Phase I to Phase IV. We have written clinical trial protocols, clinical study reports, briefing documents for regulatory meetings, and Investigator Brochures. Our documents follow ICH guidelines are written to be fully compliant with all regulatory requirements.

Document types:

  • NDA, PMA
  • IND, BLA
  • Protocol development
  • Clinical study reports
  • Briefing document for regulatory interactions
  • Regulatory submission documents
  • ClinicalTrials.gov publishing
  • Medical Publications​

Biostatistics is a necessity for clinical trials, and making sure you choose the right statistical advisor is imperative. Our extensive operational experience in this field provides a competitive advantage for your drug development program.

Protocols and statistical analysis plans are the most important documents in your drug development program. The Pharmapace statistical team has experiential knowledge about statistical methodology and their applications to clinical trials and drug development. Our biostatisticians use the most valid and powerful statistical analysis methods to maximize the probability of technical success of your program.

Keys to successful biostatistics:

  • Statistical strategy for clinical development, regulatory submissions and interactions
  • Design of pre-clinical and phase I, II, III, IV clinical trials
  • Protocol development and sample size calculation
  • Adaptive Designs, including stoppage rules and sample size re-estimation
  • Prospective observational and case-control study designs
  • Randomization scheme design and code generation
  • Statistical analysis plans
  • Support of clinical study conduct to help resolve ongoing issues
  • Conduct statistical analysesWrite statistical sections of clinical study reports
  • Expertise in meta-analysis, predictive analytics, statistical modeling and simulation
  • Plan the integrated summaries of safety/efficacy (ISS/ISEs) for Common Technical Documents (CTDs)
  • Represent sponsors in regulatory interactions, including FDA advisory committee meetings
  • Independent unblinded statisticians for Data Monitoring Committee (DMC) and interim statistical analyses
  • Due diligence assessments and gap analyses
  • Assist sponsors in interactions with potential development partners
  • Data mining for drug life cycle development
  • Stability and potency data analyses for Chemistry, Manufacturing, and Controls (CMC)

As your project manager, we proactively identify and manage every risk to help ensure you receive consistent results when you need them. Pharmapace efficiently works to streamline all aspects of study set-up, database design, sample size, database lock, and regulatory submissions.

Your study’s success depends on excellent project management to ensure deliverables are met on time, on budget and within scope. We strive for quality and efficiency in each phase of the project timeline and we achieve this by budget analysis, resource allocation, timeline management and efficient communication.

Our project managers create sustainable change by successfully completing each project and making sure our presence has left behind a legacy of process improvements and budget plans that sustain year after year.

The importance of a risk management plan is undeniable during all drug development programs. Pharmapace creates a specific risk management plan to proactively manage risks before they begin. This active, aggressive, and accurate plan provides guidance should any problems arise. We share this plan with all members involved in the project during our kick-off meeting. This open communication allows us to consider all elemental risks and create a prioritized risk mitigation plan specific to each risk.

Download Brochure 1                              Download Brochure 2

Menu