Strategikon Launches Two New Business Operation Services
Strategikon Pharma has announced that it is expanding the service offerings for their Clinical Maestro business operations platform with two offerings. Strategikon provides a SaaS product license for Clinical Maestro clinical trial RFP planning and budgeting, which includes implementation and training. Due to the effects of the pandemic, clinical trial pipelines have been disrupted by delays and changes to trial designs, increasing the use of remote technologies and tasks.
These two new services offer a Full-Service model and an Operator model. The new Operator model consists of assigning trained experts to assist, or directly operate the Sponsor’s instance of Clinical Maestro to expedite the output delivery. This Operator model is geared towards Biopharmaceutical sponsors who operate at high speed and may not have the trained staff available or the time to run clinical plans, budgets or RFP in Clinical Maestro.
A more robust model is the Clinical Maestro Full Service offering in which the Services team performs the analysis on Strategikon’s internal system and provides the Sponsor with a baseline budget and alternative scenarios, depending on the Sponsor’s requirement.
For more information, read the full release, here.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
