From Protocol Development to the CSR and every step in-between, our team of clinicians will assist you in the planning, optimisation, and execution of your clinical trial to ensure timely and high-quality completion.
We put the clinic in clinical research with our team of experts, including physicians and pharmacists
Whether you need a Clinical Research Physician to lead the study or an entire team of Clinical Research Scientists to support with the trial, you can trust that we’ll provide the right experts to guide and drive medical consultancy throughout your clinical trial.
We will build a comprehensive clinical services package tailored to your needs:
- Study design and protocol development
- Statistical Analysis Plan development
- Data review and query management
- Medical monitoring
- Data and Safety Monitoring Board (DSMB) participation
- Clinical project management
- KOL selection and site evaluation
- CRO/vendor selection and management
- Clinical Study Report development
Study design
From experimental randomised parallel group or crossover studies to observational cross sectional or case control studies – we understand the complexities of the various subgroups of study designs. We recognise your challenges in getting the trial design right from the outset and it is our commitment to help you develop the most robust study design to deliver on your target outcomes.
Data Review
We pride ourselves on our reputation for integrity and excellence, and this extends to the integrity of your clinical trial data. We have a tried and tested formula for comprehensive data review and query management, with efficiencies built in the process for reconciling adverse event data. We also specialise in providing an independent data review service, even after an initial first pass of the data review has been conducted, to ensure your data is of the highest quality at the most critical points prior to data analyses.
Clinical Writing
Our team of in-house medical writers work hand-in-hand with the clinical team to efficiently support the communications activities throughout your clinical trial. We have extensive experience in the preparation of study protocols through to clinical study reports across a broad range of therapeutic areas. We will ensure your study documentation is of the highest quality, minimising the need for onerous documentation resubmissions throughout the course of the study.
Feeling overwhelmed by unclean data?
Need assistance getting your eCRF clean in time for database lock?
Need assistance in optimising your clinical development strategy?
Hit a roadblock with development of your protocol?
Testimonials
“Working with Dr. Ludwig had been great at both personal and professional levels. We believe that if Dr. Ludwig continues to commit to her clients based in Japan, it is very likely that we will continue doing business with her in future projects. ”
Senior Project Manager, Japan
Case Studies
Case study 1
Case study 2
Case Study 1
Scenario
Our client conducted a randomised, placebo-controlled Phase 2 study that evaluated the addition of a novel therapeutic to standard care for venous leg ulcers.
157 patients were recruited across 21 sites in the USA, and an independent medical review of the data was required to ensure the data collected by a contract research organization was accurate ahead of study analyses.
Our Solution
MMD reviewed all patient data collected during the trial and generated queries for 156 subjects. Subject data for review included, but was not limited to, medical history, laboratory values, concomitant medications, and adverse events.
MMD also went above and beyond to re-create the SAE list from scratch in order to clarify issues that arose from combined reporting of co-manifestations and follow-up reports from further scrutiny of hospital notes.
End Result
- MMD triaged several queries across 99% of trial subjects, and highlighted issues that could potentially confound the study results if not rectified (e.g. subject data indicative of renal failure at screening etc.)
- The client were able to obtain clear results from the study and subsequently made a significant business decision to shift priorities towards alternative intellectual property assets.
Case Study 2
Scenario
An international sponsor was conducting a phase I bridging trial in Japan and required an English-speaking medical monitor, available in the same time-zone as the trial sites.
Our Solution
My Medical Department established relationships with the trial sites on behalf of the sponsor, providing real-time medical monitor support including eligibility packet review; analysis of potential DLTs; and regular review of the risk-benefit balance of the product in the study population, as well as travelling to Japan to conduct SIVs and DSMBs in-person.
End Result
- Strong collaborative relationships built with the study sites on behalf of the overseas sponsor
- In-person representation of the sponsor at key on-site meetings.
- Medical representation of the overseas sponsor according to the working hours of the trial sites
- Database lock within 2 weeks of LPLV
“Working with Dr. Ludwig had been great at both personal and professional levels. We believe that if Dr. Ludwig continues to commit to her clients based in Japan, it is very likely that we will continue doing business with her in future projects. ”
Senior Project Manager, Japan