Outsourcing-Pharma presents a roundup of eClinical news, including an update at Medidata to drive growth in 2012.
Medidata Solutions has released a new version of its randomisation and trial supply management software, Balance. The update adds an alternative randomisation methodology to meet the needs of more users.
“With the broader capabilities in Balance’s new version, sponsors and CROs can now choose either permuted block or dynamic allocation randomisation”, Glen de Vries, president of Medidata, said.
Users can compare the two approaches to patient enrolment by running simulations in Balance. Once an approach is chosen the randomisation and treatment dispensation instructions are sent to investigative sites through Medidata Rave. Growth of Balance is important for Medidata this year.
“While cross-selling reportedly more than doubled in 2011, in part due to new product introductions including ClinicalForce, Insights, and traction from solutions like Balance, we believe that this feat will be challenging to achieve in 2012”, Sandy Draper, equity analyst at Raymond James, wrote in March.
A reorganisation at invivodata has integrated its patient-reported (PRO) outcome consulting business into the clinical outcome assessment (COA) division. The business, formerly called PRO Consulting, is now known as invivodata Consulting.
“Now our clients will interact with one organization, regardless of whether their needs centre around critical pre-study consulting work, proven eSolutions for COA data capture in clinical trials or, as in many cases, both”, Doug Engfer, president and CEO of invivodata, said.
Cape Cod Clinical Research, Inc (CCRI) has introduced a web-based document management system, TrialDOCS. The US Food and Drug Administration- (FDA) compliant tool allows sites, sponsors, and the CRO to access regulatory and source documentation remotely.
“Remote monitoring is a concept whose time has finally come to the US. By providing organisations with a secure system to manage all documentation in a clinical trial…remote monitoring can be successfully realised”, William Baker, president and founder of CCCRI, said.