Biometrics

CDISC Conversion

CDISC Mapping and Submission Solutions

Our programmers are actively involved with CDISC initiatives and working groups giving them access to the latest standards. We have a proven track record of implementing complex CDISC mappings for many clients across pharma, biotech, academia and medical devices.

As your partner, we’ll leverage our indication-specific knowledge to guide you through the full data mapping process, including:

  • Twenty-plus years of Data Mapping & Standardisation
  • Experts in CDASH, SDTM & ADaM
  • Highly experienced programming team with statistical knowledge and expertise to increase efficiency and transparency

CDISC Solutions from Raw Data to Submission

Standardizing data into CDISC format is a difficult and time-consuming task requiring expert skills and specialist experience to ensure your study meets all the requirements for submission.

Due to updated rulings from the FDA/PMDA, there is now, more requirement than ever to submit data in CDISC format. For the FDA, any study that started on or after December 2016 requires CDISC standardized data. Similarly, a newer ruling for the PMDA has also come into effect for submissions after April 1st 2020.

Our dedicated team of CDISC specialists with combined experience in SDTM, ADaM and associated documentation so no need for separate teams for standardization or analysis. They work across all CDISC standards and have supported many clients with submission efforts to regulatory authorities.

Why choose Alira Health for CDISC Conversion?

The CROS NT and Alira Health biometrics team has provided expert statistical guidance for over 500 projects, including regulatory communication and submissions, study-based data management, biostatistics, and statistical programming. You will benefit from our:

  • Exceptional customer service and site relations
  • In-depth expertise across the entire clinical trial process
  • Flexible and tailored service delivered by multidisciplinary and global teams
  • Frequent, transparent, and professional communication
  • Guarantee we will lead your study efficiently, safely, and successfully

CDISC News

Publications September 16, 2022
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials
The rise of technology in clinical research allows us to capture meaningful aspects of health in clinical study participants.
Biometrics Clinical eCOA
Publications September 7, 2022
The Promise and Reality of Decentralized and Hybrid Clinical Trials in Europe Today
To understand the challenges related to hybrid and decentralized trials and ways to overcome them, we spoke with Dr. Hervé Solatges, Product Management, Evidence, and Innovation (DCT(...)
Clinical Decentralized Clinical Trials Hybrid Clinical Trials
Publications September 5, 2022
Taking In-Licensed Biologics to Market: Challenges, Complexities, and Ways to Overcome Them
Taking a biologic through drug development to market is highly complex and filled with challenges. To understand these challenges, their implications and how to overcome them, we spoke(...)
Biologics Clinical Drug Development
Events August 10, 2022
DPHARM
We are pleased to announce that we will be sponsoring and attending DPHARM, a unique event focused on the latest innovations that modernize clinical trials.
Clinical Decentralized Clinical Trials DPHARM Patient Centric
Publications August 2, 2022
GMP Manufacturing and IND-Enabling Studies of a Recombinant Hyperimmune Globulin Targeting SARS-CoV-2
The last two years have brought forward tremendous advances in the development of prophylactic and therapeutic approaches for the treatment of SARS-CoV-2 infections.
Clinical CMC Vaccines
Multimedia May 19, 2022
Fireside Chat Replay: Latest Developments in Oncology Supportive Care
In this fireside chat, we sit down with two medical experts in oncology and discuss some of the fascinating developments that are happening in the oncology supportive care field.
Clinical
Events May 19, 2022
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
Biometrics Clinical Life Sciences Regulatory
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.