Operational Models
Our core services, clinical data management, biostatistics, and statistical programming, are anchored by extensive early phase experience, real time access to biometrics experts and cost-effective technologies.
We can support all the biometrics activities on a project, from protocol input through to database lock and the final statistical analysis and the clinical study report.
Do you have a clinical CRO without biometrics capabilities, a preferred data management provider or a trusted biostatistician who will be involved in the project? Our flexible approach allows for a tailored solution to provide the specific biometrics services that are required for your project.
Full-Service Biometrics
We have successfully completed several projects where our team worked directly with the sponsor as the sponsor’s inhouse biometrics team. We assume full operational control of all biometrics deliverables, including protocol development, database design and development, data management, and the planning and execution of the statistical analysis per our standard operating procedures. Several sponsors have engaged us for their follow-up studies after the successful initial collaboration.
We also collaborate with several local and global CROs to provide a full-service offering. Under this model, our team collaborates with clinical CROs to form a project team with a single point of contact, assuming full responsibility for all biometrics activities and deliverables per our standard operating procedures.
What our clients are saying:
“The team at RGCRO have strong expertise and experience, and provide an efficient and high quality product. They are easy to work with and helpful in navigating the data management and statistical analyses processes of clinical trials through all phases. The stats team especially are great at making things easy to understand for the less-stats savvy among us, and are able to provide practical suggestions and opinions to help produce the best study outputs and reports.”
Nicole Kruger – Director of Clinical Operations
Certa Therapeutics
“Resolutum Global has a highly experienced and friendly team that provided a local solution in biometrics for our Phase I clinical study. The team showed their dedication by catering for our needs in a timely and professional manner”
Dr Francesca Mercuri – Director, Operations
ENA Respiratory
“Resolutum Global have now supported two clinical studies sponsored by Amplia and on both occasions their technical know-how, responsiveness and ‘can-do’ attitude have been excellent. Working with a local data management provider that understands our priorities has also been a refreshing change for us.”
John Lambert – CEO and Managing Director
Amplia Therapeutics
“Avecho engaged Resolutum Global for the first time on our recent Phase I PK study. Moses and the team were highly professional and capable, whilst being agile enough to accommodate the changing needs of small Biotech. Data management and stats were performed to the highest quality, on time and on budget. We would definitely use Resolutum again and recommend them to our peers in the space.”
Paul Gavin – CEO
Avecho
Data Management
Our data management team collaborates with other organizations to design, build and maintain EDC solutions on the partner’s behalf. We have supported several Australian CROs faced with resource constraints, ensuring that the trial start-up timelines were met, handling all mid-trial database modifications, and locking the database.
We also collaborate with several organizations to provide an end-to-end data management solution. Under this model our team assumes full responsibility for all data management deliverables, working with the partner’s clinical and biostatistics team to deliver the trial data for analysis. This model is frequently used by our not-for-profit and academic clients who requires only data management support.
Biostatistics
Our biostatisticians have extensive experience helping clients to design clinical trials. We support all aspects of protocol development, including sample size calculations, endpoint identification and advising on statistical methodology.
Our team helps to manage vendors by overseeing all statistical deliverables ranging from the review of the statistical analysis plan (SAP), the trial results (tables, listings, and figures), CDISC data packages, and the clinical study report, generated by the vendor.
What our clients are saying:
“Thank you! You’re our first go-to shop for biostats/biometrics, wherever we land!”
Shannan Lynch – PhD, Senior Director
Clinical Science and Research Revelation Biosciences, Inc. USA
Statistical Programming
Our statistical programmers have complemented sponsor teams with inhouse data management and biostatistics teams, supporting all the statistical programming activities from creating CDISC data packages to generating the tables, listings, and figures in accordance with the sponsor’s statistical analysis plan.
We also support most of the Australian CROs by providing additional statistical programming resources when they are faced with resource constraints by producing some or all the programming deliverables on their behalf.
What our clients are saying:
“Once again, we are grateful for your expedited timeline of the topline data for the SAD/MAD cohorts to date.”
Sam Lee – Ph.D, President and Interim Co-Chief Executive Officer
Cocrystal Pharma Inc. USA
Biostatistics and Statistical Programming
Our team has extensive experience partnering with other organizations that only offers data management services.
Under this model, our biostatistics and statistical programming team assumes full responsibility for all biostatistics deliverables, working with the partner’s data management team to perform the data analysis.
This model is frequently used by Australian CROs without inhouse biostatistics support and clinical research units that utilize electronic source data (eSource) platforms.
What our clients are saying:
“RG was absolutely excellent for the statistical analyses for our phase 1 trial and conducted all aspects of the project in an extremely efficient, professional manner. RG’s attention to every detail was evident in the excellent quality of the statistical analysis plan, table shells, final tables, figures, and listings, and CDISC datasets. Their effective and responsive communication promoted a seamless transition from study execution to reporting the trial results.”
Lyn Frumkin – MD, PhD
SPARK at Stanford, USA
Rescue Studies
Our team has extensive experience in rescuing ongoing studies when other biometric providers need help. Our inaugural project was a rescue project that was successfully delivered on time and within budget.
On request, we work with our partners and sponsors to identify the gaps and bottlenecks in a trial, and then we design and execute a rescue plan to recover the trial timelines.
We are regularly approached by larger CROs to support projects that must be completed in Australia under the Australian Research and Development Tax Incentive scheme.
What our clients are saying:
“RG has been a very diligent, proactive and professional partner to help complete a complex project of a certain vintage. The quality of its medical writing personnel is extremely high and RG has consistently pursued a collaborative path to resolve long-standing issues to every stakeholders’ appreciation. The Managing Director is very approachable and pragmatic; Moses Mwangi is a trusted partner whose transparency, candour and expertise exceeds expectations. I would certainly recommend RG as a very good vendor in a research industry where reputation matters, and those that add value without adding cost are priceless.”
Vincent Ruffles – Senior Manager
Clinical Development Life Sciences