Alimentiv Statistics Exceeds the Expectations of Clients Running Clinical Trials

Alimentiv Statistics specializes in Clinical Statistical Analysis, Clinical Trial Design and Data management of clinical research for pharmaceutical, biotechnology & medical device companies. Our unique expertise along with the flexibility and affordability of our services has helped make Alimentiv Statistics an integral and sought-after CRO.

Why Alimentiv is the right partner for your project.

Experience

Therapeutic Area agnostic statistical and data management expertise with over 40 years of providing quality expertise as a clinical trial CRO.

Reputation

Operational excellence due to a team of eminently qualified and accredited statisticians resulting in over 95% of our clients being from satisfied referrals.

Affordability

Our industry is one with high costs. Due to our niche focus, we are able to provide proposals that are highly competitive without compromising on outcome and quality.

Our Services

Statistical Consulting

The way your team plans, collects, manages, analyzes, interprets and prepares clinical data can significantly impact the success of your trial. Our statistical consultancy will help deliver objective perspective to clients.

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BioStatistic Services

Clients trust us to align study design and analyses with their business objectives and regulatory strategy by delivering a vital statistical strategy that helps mitigate risks during product development.

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Data Management

We provide dedicated clinical data management services from database build to database lock and archiving. Our team is committed to customizing data solutions that emphasize cost efficiency, data integrity and accuracy.

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Our Distinct Advantage

Industry research has shown that pharma and biotech companies are looking to avoid the trap of committing to inflexible contracts from a large contract or clinical research organizations. There is a real trend towards working with specialized CRO consulting firms like Alimentiv Statistics because of the unique expertise we can provide, the flexibility we can offer and the affordability of our services.

Access and download content such as whitepapers, reports, infographics, eGuides and articles on Biostatistics, Clinical Trial Design, Clinical Statistical Analysis, Data Management and the overall Clinical Trials Sector.

Statistical Consulting

The way your team plans, collects, manages, controls, analyzes, interprets and prepares clinical data can significantly impact the success of your trial.

An insightful plan is the pathway to success. Alimentiv Statistics brings its over 35 years of experience to help solve the unique and complex challenges and requirements clients face throughout the clinical development process. Clients have trusted Alimentiv throughout the years to help align study design and analyses with their business objectives and regulatory strategy by delivering a vital statistical strategy that helps mitigate risks during product development.

Alimentiv Statistics’s advisory services help you conduct trials that are informative, compliant and cost-effective. Members of Alimentiv’s statistician team are accredited Professional Statisticians through both the Statistical Society of Canada (SSC) and the American Statistical Association (ASA) averaging over 15 years of progressive experience. Having such a breadth of experience among our statistical team enables us to provide our clients with services that make a real impact.

Our statisticians will provide guidance on your study design that will help answer your research questions with high confidence while meeting regulatory requirements and subject to business constraints.

Operational Considerations:
  • Study Design, emphasis on adaptive-by-design
  • Causal Analyses for post-marketing
  • Statistical methodologies to maximize efficiency
  • Protocol Development & Review
  • Data Quality Oversight via the creation of Statistical Monitoring Reports
  • Ensuring study size is optimal
  • Safety Surveillance
  • Pharmacokinetics & Pharmacodynamics
  • Observational, registry, real-world evidence study designs and analyses
  • Determine which statistical approach is best (Bayesian, precision, etc)
  • Registered CDISC, SDTM and ADaM data service provider
  • Program level strategies
  • Statistical training for non-statisticians
  • Consulting services to regulatory bodies, FDA, EMA, and Health Canada
  • Pharmacovigilance
  • Statistical Analysis Plans (SAPs)
  • Technology consulting services such as data conversion, eTMF, EDC, IVR, etc

An insightful plan is the pathway to success.

Alimentiv has exceeded client expectations by providing timely, accurate data and analytics leading to expedited time-to-market and lower development costs.

Whether you call it clinical trial statistical analysis, Clinical Biostatistics, Biostatistics for clinical trials, Statistical analysis in clinical trials, or Statistical analysis for clinical trials, the way your team plans, collects manages controls, analyzes, interprets and prepares clinical data can significantly impact the success of your trial.

Alimentiv Statistics statistical or BioStatistics consulting services help you conduct trials that are informative, compliant and cost-effective. Clients trust us to align study design and analyses with their business objectives and regulatory strategy by delivering a vital statistical strategy that helps mitigate risks during product development.

BioStatistics, Programming & Analysis Services include:

  • Study Design, emphasis on adaptive-by-design
  • Causal Analyses for post-marketing
  • Statistical methodologies to maximize efficiency
  • Protocol Development & Review
  • Data Quality Oversight via the creation of Statistical Monitoring Reports
  • Ensuring study size is optimal
  • Safety Surveillance
  • Pharmacokinetics & Pharmacodynamcs
  • Observational, registry, real-world evidence study designs and analyses
  • Determine which statistical approach is best (Bayesian, precision, etc)
  • Registered CDISC, SDTM and ADaM data service provider
  • Program level strategies
  • Statistical training for non-statisticians
  • Pharmacovigilance
  • Statistical Analysis Plans (SAPs)

Unleash Your Data

Our statisticians can design your study to answer you research questions with high confidence while meeting regulatory requirements and subject to business constraints. During study implementation, ongoing analytical reporting supports centralized risk-based monitoring and safety review.

Members of Alimentiv’s statistician team are accredited Professional Statisticians through both the Statistical Society of Canada (SSC) and the American Statistical Association (ASA) averaging over 15 years of progressive experience. Having such a breadth of experience among our statistical team enables us to provide our clients with services that make a real impact.

Data Management

Clinical data management (CDM) is an essential part in the data collection phase of clinical research. CDM ensures colelction, integration and availability of data, hopefully leading to high-quality, reliable, and statistically sound data is done in accordance with regulatory standards to obtain quality information that is complete and error-free.

The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Ultimately, Drug developers want ensure that the data delivered to regulatory bodies is reliable and that clinical data captured guides proper treatment decisions, which impact patient health.

Explore Our Clinical Data Management Services

Clinical data quality and integrity are key to clinical trial success. This helps ensure that drug companies deliver reliable data to regulatory bodies and helps guide proper treatment decisions for better patient health. McDougall Scientific provides dedicated clinical data management services from database build to database lock and archiving. Our method to capture, manage, clean and deliver data is efficient and scalable.

We offer a full suite of services utilizing traditional paper-based solutions and/or electronic data capture (EDC) solutions. Our team of clinical database programmers are well versed in a variety of leading EDC platforms. Our clinical data management team is committed to customizing data solutions that emphasize cost efficiency, data integrity and accuracy.

McDougall Scientific is a CDISC Platinum Solutions Provider, our team of Clinical Data Managers are certified by the Society for Clinical Data Management (SCDM) and are supported by compliance-driven Standard Operating Procedures. McDougall Scientific’s clinical data management services follow applicable laws and guidelines from regulatory agencies (e.g. ICH GCP and 21 CFR Part 11)

Our Suite of Data Management Solutions

Consulting (strategic program planning, protocol review, etc.)

CRF/eCRF design and development

Real-time study metrics viewing and reporting

EDC consultation, design, selection

CRF Annotation & Review

Medical coding (MedDRA & WHODD)

Data capture and management using multiple EDC systems

Edit checks Programming & Testing

SAE Reconciliation

Paper setup and management

Query Management

Custom Programming

Data Management Plan (DMP)

Support for Safety Monitoring

Database build, design and implementation

SAE Reconciliation

Database lock

Data validation, review, cleaning, quality control

Database QA acceptance sampling prior to database lock

Database archival

Data processing through double data entry

Data captured using CDASH (Clinical Data Acquisition Standards Harmonization) standards.

Database transfer

24/7 access to secure real-time reports and metrics allows monitoring of site enrollment and activities

Follow benchmarks set by SCDM and CDISC

Meet with our experts