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Re-Engineering Drug Development II: Clinical Data Collection & Management

 
• By Antonio Regalado

Despite a history of failed products, start-up companies are looking to reinvent how data from clinical trials is collected and managed. Firms are trying to replace the point solutions of the past with broad software offerings that can take clients from "site to submission."

Eli Lilly & Co. Parexel International Corp. Quintiles Transnational Corp. Covance Inc. Pharmaceutical Product Development Inc.

In front-page cover age of the pharmaceutical industry's latest proposed mega-merger, a Wall Street Journalheadline trumpeted "Cost of Drug Research...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Finance Watch: Scorpion Spinout Antares Launches With $177m For Precision Medicines

 
• By Mandy Jackson

Private Company Edition: Antares’ lead asset will enter the clinic in 2026 after Lilly committed up to $2.5bn for Scorpion’s Phase I/II PI3Kα inhibitor STX-478. Also, Amplify raised $200m for its first biotech VC fund and Mosanna raised an $80m series A round, among other financings.