Archivo de la categoría: Clinical trial

Veeva Systems has partnered with Medidata Solutions to offer the life science industry’s first cloud-based end-to-end solution that integrates clinical documentation and trial development. The two companies will integrate Vault eTMF, Veeva’s electronic trial master file (eTMF) content management application, across the Medidata Clinical Cloud, offering life science companies and their global partners a complete clinical technology solution with a searchable central repository for all clinical documentation.

“Within the industry, there is an emerging demand for an eTMF to more consistently manage documents within a clinical trial,” said Alan S.Louie, Ph.D., research director, IDC Health Insights. “With the industry shift away from individual applications to more comprehensive eClinical solutions, seamless integration of applications and features such as eTMF into existing eClinical platforms should help leading life science companies to more fully and transparently manage overall trial efforts and improve process efficiencies.”

As clinical trials become more and more complex, the need for dependable document storage combined with real-time data accessibility is vital. The partnership will meet this need, advancing technology platform offerings in clinical development by facilitating efficient management of the trial master file collection. The integrated solution also provides secure document exchange between sites and sponsors, reducing the need for separate enterprise collaboration systems and portals. The collaborative nature of the clinical research team also demands a solution that is globally accessible and meets both regulatory and security needs.

Clinical trial, Drug Information Association, Electronic data capture, Food and Drug Administration, Medical, Medidata, Medidata Solutions

Medidata Solutions to Show New Clinical Cloud Products, Enhancements at DIA

junio 25, 2012 Richard

Medidata Solutions will showcase new products and features that broaden its clinical cloud platform at the upcoming Drug Information Association’s (DIA) Annual Meeting, June 24-28 in Philadelphia, Pa. Addressing new industry regulations, the need for broad safety reporting and improvements to site monitoring processes, these enhancements to Medidata’s comprehensive solutions will offer drug developers new capabilities for overcoming key research challenges.

“Sponsors are under more pressure than ever to cut costs, improve efficiency and adhere to increased regulations, requiring innovation and real-time operational analytics across the clinical research chain from concept to conclusion,” said Glen de Vries, president of Medidata Solutions. “We are continuously broadening our solution set to empower sponsors to improve their research clinical systems at every point in the clinical process, including trial planning, monitoring, site payments and safety.”

From booth #3101, Medidata will be providing demos of key products and new features to enable sponsors to achieve key goals, including:

Driving a New Monitoring Paradigm
The company’s first
solution for managing site quality and the latest addition to the
Medidata Insights™ family of clinical business analytics offerings, Medidata
Insights SQM™ combines advanced data visualization with seamless
real-time data availability with the rest of Medidata’s platform to
deliver turnkey site quality management – further enabling the
industry’s shift to simplified remote monitoring of site and data
quality resulting from the 2011 FDA clarification on source document
verification (SDV).

Automating Safety Processes with Electronic Adverse Event Transfer
To
help drug developers meet post-marketing expedited reporting
obligations within the new European pharmacovigilance legislation, Medidata
Rave Safety Gateway™ expanded its capabilities for sites to
electronically transfer non-serious safety case data – in addition to
serious safety case data – to sponsors’ safety systems, eliminating
paper-based manual processes, reducing query cycles between sites and
sponsors’ safety groups and minimizing reconciliation between safety
and clinical databases.

Ensuring Timely Investigator Payments
Due to the
complexity of triggering investigator payments from sponsor-set
milestones, site payments are often delayed. The out-of-the box
integration of Medidata
CTMS™ and Medidata
Rave^® electronic data capture (EDC) improves the
efficiency of clinical operations, streamlining workflows in areas
such as site monitoring and site payments. Now, Medidata Rave EDC data
is pulled into Medidata CTMS™ monitor reports, increasing the accuracy
of reporting and timeliness of payment triggers.

Assuring Market Value Compliance and Faster Budget Agreements
Designed
for sponsors receiving investigator-sponsored proposals from sites, Medidata
Grants Manager Investigator Initiated™ offers drug developers
clarity and uniformity in judging pricing and conduct of their
submitted funding requests.

Ensuring the Right Randomization Approach to Meet Study GoalsMedidata
Balance™ now provides the block randomization methodology in
addition to dynamic allocation randomization, extending its use to new
segments of the life science industry by permitting researchers to use
the approach that best suits their study goals.

Cancer Genome Atlas, Clinical trial, Medical, NextBio, Translational medicine

NextBio Clinical Extends Life Sciences Platform From the Bench to Translational Medicine

abril 23, 2012 Richard

Image representing nextbio as depicted in Crun...

NextBio today unveiled NextBio Clinical, an extension of the company’s existing life sciences platform to translational medicine applications such as biomarker discovery and clinical trial optimization. Adding curated genomic, molecular and clinical profiles from thousands of individual patients to the platform’s existing repository of data from animal and cell line models, NextBio Clinical enables the earlier application of clinical information to enhance research and development.

“Since 2004, NextBio has been addressing the research needs of scientists at academic institutions, pharmaceutical and biotech companies with our cross-technology platform for integrative data analysis,” says Saeid Akhtari, NextBio President and Chief Executive Officer. “Now, with NextBio Clinical, we directly address the challenges of taking genomics into clinical research for the development of therapeutics and companion diagnostics. By providing patient-centric data and analysis, we facilitate biomarker-driven research that can accelerate the process of translational drug discovery.”

Mr. Akhtari concluded, “With the growing availability and decreasing cost of obtaining individual patient data moving genomics into clinical applications, NextBio Clinical is a natural extension for both our platform and our clients who have been using NextBio in their research for many years.”

NextBio Clinical aggregates and correlates terabyte-scale collections of private and public cross-platform ‘omics’ data, experimental data from cell lines and other sources, and clinical data from individual patients and population studies. Controlled vocabularies and the platform’s semantic framework eliminate confounding gene, disease and compound annotations, facilitating applications of this content at all stages of research, from early stage experimentation to repositioning approved drugs.

“With efforts such as The Cancer Genome Atlas, the International Cancer Genome Consortium and others, the growth of patient-level data in the public domain has been enormous. Simultaneously, efforts like the Cancer Cell Line Encyclopedia are transforming our understanding of pharmacogenomics with cell line models. We are excited about the potential of integrating these diverse data within the framework of NextBio Clinical,” said Ilya Kupershmidt, co-founder and Vice President of Products at NextBio.

Organizations can use the NextBio Clinical platform to accelerate drug discovery by applying human biology earlier in the discovery process, to discover and develop predictive biomarkers, and to optimize clinical trial design and patient selection to reduce development timelines and increase the chance of successful approval for new therapies.

Mr. Kupershmidt added, “By enabling our users to bring patient genomic data into the clinical development process at an early stage, we hope to help improve the pace and success rate at which biomarker-based therapeutics are approved for clinical use.”

Ilya Kupershmidt, Co-founder and VP of Products at NextBio, will describe NextBio Clinical in his talk at Bio-IT World 2012, titled “Patient-centered solutions for translational medicine” on Wednesday April 25, 2012 from 3:00-3:15 p.m. The meeting is being held in Boston, MA at the World Trade Center from April 24-26.

NextBio representatives are also available for additional information or product demos at Booth 326 in the exhibit hall.