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Study Reporting & Analysis Services

We offer a range of outsourced and insourced Study Reporting & Analysis Services.

“These narratives have the least amount of changes I have seen in the last 10 years. They are amazingly good. We don't usually get them in this great of shape.”

Client since 2017

The common thread across the Veramed team is a genuine focus on quality first

Tailored solutions

We understand that different clients require different levels of support, and this enables us to recommend solutions that are tailored to your needs – from outsourced reporting and delivery of large submission studies, to providing insourced consultancy services, for example for SDTM conversion or CDISC implementation.

Vast experience

Our programing team has vast experience in SAS and R, and is well-versed in providing high quality support across the board. We have experience in numerous reporting environments, client systems (and of course our own in-house solution) and all our programmers are trained on the Veramed Excellence Program to ensure that technical aptitude is balanced effectively with consultancy and customer focus skills.

Quality Control process

  1. Specifications review
  2. Self QC
  3. Independent QC
    • Double programing / code review
    • Output review
    • Consistency checks
    • Sensibility checks
    • Log checks
  4. Statistician review of all outputs
  5. Finalization of QC log

Consultancy

  • CDISC Review and Gap Analysis – our most experienced programmers are skilled in performing a review of CDISC compliance and quality prior to submission.
  • Programing support – we can provide Veramed programmers on a full-time, part-time or adhoc basis to work as part of your internal team (e.g. as contract/consultant programmers).

Check out our wide range of statistical consultancy service offerings on our consultancy page.

Setup

  • Protocol review/input – statistical support in the development of the clinical trial protocol (and amendments) with consideration to the recent ICH E9 addendum around estimands.
  • Randomization development – producing randomization lists and advising on the most appropriate randomization method for a particular study.

Midstream activities

  • Vendor oversight – we offer third party vendor oversight to ensure the highest quality for your trial – including planning for success, management of timelines and review of programing and CDISC deliverables.
  • Data Management Programing – from edit checks through to advanced visualizations, we routinely work with data management to help you identify complex data quality issues at the earliest possible point.
  • DMCs / DSMBs – we provide and prepare the blinded and/or unblinded analyzes for committee members with support from our statistical team. Our expert statisticians will ensure this process runs smoothly.
  • Interim Analyzes – we offer expert advice on the design, management and implementation of interim looks at the data, whether blinded or unblinded, and we can guide you through this complex process.
  • Data Review Meetings
  • Protocol Deviation determination and review

Analysis and reporting

  • Specifications – our programmers are trained in authoring and reviewing specifications for datasets, including Tables, Listings and Figures to ensure that programing is efficient and focuses on quality from the outset.
  • Study Analysis and Reporting – we can program analysis datasets of all levels of complexity and report high-quality Tables, Listings and Figures. As a result, we routinely achieve zero client review comments.
  • CDISC SDTM Conversion – our programing team is trained to provide accurate and compliant CDISC SDTM datasets converted from a variety of different data sources.
  • CDISC ADaM Implementation – we are trained to specify and provide accurate and compliant CDISC ADaM datasets. We are proud of our 100% record to date for submission quality.
  • Statistical Analysis Plans – developing and/or reviewing clear and detailed SAPs and supporting mock output shells, in accordance with ICH E9, for clinical study reports, interims and DMCs.
  • Patient Profiles – We can provide basic profiles, visualizations, SAE and withdrawal narratives – depending on the requirements of your study.

Post reporting / Submission activities

  • CDISC Documentation – We develop Reviewer’s Guides (SDRG, ADRG), Define-XML, analysis results metadata and annotated CRFs.
  • Data Anonymisation – We deliver support macro development and implement de-identification and anonymisation techniques to fulfill transparency requirements, along with disclosure and research requests while safeguarding the privacy of individuals.
  • Patient Profiles – We can provide basic profiles, visualizations, SAE and withdrawal narratives – depending on the requirements of your study.
  • Supporting ISS/ISEs
  • CSR input/review
  • Publications – we provide support throughout the publication process, from the concept, identification and implementation of appropriate analyzes, right through to the interpretation of the results.
  • Strategic and collaborative support to help maximize remedy launch impact and ensure commercial success for your remedy.

Get in touch

CONTACT

Have you found what you are looking for? Learn more about our other services below or get in touch.

Statistical Consultancy

We provide a comprehensive statistical service, from study design through to submission and beyond.

Data Monitoring Committees (DMC)

We provide a wide variety of DMC offerings, from one-off consultation to full end-to-end Statistical Data Analysis Centre with administrative and logistical support.

Functional Service Provider

Our bespoke FSP relationships allow us to partner with you to understand your requirements, build trust, enhance quality and develop long-term, collaborative relationships.

Evidence & Value Generation

Through RWE, Evidence Synthesis, and Evidence Dissemination we’ll help you fill tricky evidence gaps and get your remedy to patients who need it, faster.

Biotech Due Diligence

A Veramed & Weatherden partnership, we offer data driven due diligence of your assets to help you better seek potential acquirees or partners.

Automation

Our Automation, Efficiency and Standards group helps you to assess, evaluate and implement enhancements to your clinical trial workflows.

Functional Service Provider

Statistical Consultancy

Biotech Due Diligence

Data Monitoring Committees (DMC)

Evidence & Value Generation

Automation

Veramed’s quality and attention to detail has always been impressive, and married with their excellent communication and timely execution, they are the first choice vendor for me in statistics and programming.

Client since 2017

Veramed stand out for their obvious care and support of their employees augmented into our teams. They are strong advocates for their staff and their development needs which inspires us as sponsors to support that development as much as possible.

Client since 2012

It’s great to work with such a proactive team...we also very much appreciate how agile Veramed as a company has been to ensure that we can meet our changing priorities and last minute requests for additional support.

Client since 2017

Veramed is the number 1 CRO that we have ever worked with, the quality and communication that we have received has been excellent and we definitely want to work with Veramed on our studies moving forward.

Consultancy client since 2020
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