Data management

Pfizer, GSK, Sanofi, Others Take Issue with FDA’s CMO Draft Guidance

24-Sep-2013 By Zachary Brennan

Pfizer, GlaxoSmithKline, Sanofi, and at least ten other big pharma companies, CMOs and industry groups are criticizing aspects of the recent FDA draft guidance governing quality agreements.

Update

InVentiv partnership will increase its access to trial site database

19-Sep-2013 By Zachary Brennan

iCTRS (inVentiv Clinical Trial Recruitment Solutions) has partnered with ViS Research to accelerate the way it evaluates clinical trial sites.

FDA final guidance on eCRFs skirts questions raised by ACRO, Quintiles

19-Sep-2013 By Zachary Brennan

The US FDA has finalized guidance on electronic case report forms (eCRFs), which offers advice for sponsors and CROs on how and in what cases to capture electronic source data. 

Evotec, Harvard Form ALS Research Partnership

17-Sep-2013

German CRO Evotec and the Harvard Stem Cell Institute have partnered to discover compounds that might prevent or slow ALS (amyotrophic lateral sclerosis) and other motor-neuron diseases.

Theorem, CRL Form Alliance to Offer ‘Seamless’ Nonclinical to Clinical Transition

16-Sep-2013 By Zachary Brennan

Theorem Clinical Research and CRL (Charles River Laboratories) have partnered to help clients transition between preclinical and clinical testing.

CROS NT Jumps into Medical Device Space with US Acquisition

12-Sep-2013 By Zachary Brennan

European CRO CROS NT has acquired US medical device CRO Stat-Tech Services to try to take a slice of the growing medical device trial sector. 

First CRO Implements Accreditation Program for CRAs Monitoring Trials

12-Sep-2013 By Zachary Brennan

In a first for CROs, INC Research has implemented an international accreditation program for its clinical research associates to further understand trial monitoring and ensure consistency for biopharma sponsors.

India Offers Insider Look at CRO-Sponsor Relationships for Global Trials

12-Sep-2013 By Zachary Brennan

India’s top drug regulator on Wednesday unveiled a list of all the pending clinical trials before its apex committee, which includes information on what the top CROs are working on in the subcontinent. 

Quintiles CEO: CRO Industry at a ‘Tipping Point’ in Progressing Drug Development

11-Sep-2013 By Zachary Brennan

Clinical trial sponsors are now asking CROs to do more as an industry and as the top contracting companies build teams of scientists and physicians as varied as some hospital chains, sponsors’ reliance on outsourcing may have yet to peak.

inVentiv Sues US HHS Arguing New Rules Restrict Rx Reminders Business

10-Sep-2013 By Zachary Brennan

inVentiv Health company Adheris filed a lawsuit against the US Department of Health and Human Services (HHS) last week claiming that a new regulation imposes unconstitutional restrictions on part of its patient reminder business.

Covance Sees Multiple Avenues for Margin Expansion, CFO Says

10-Sep-2013 By Zachary Brennan

Covance’s IT expenses are expected to taper off in 2014, which could contribute to driving wider margins for the CRO, Covance CFO Alison Cornell said Monday.

PSI Makes Further Inroads into Italy, South Africa and India

05-Sep-2013 By Zachary Brennan

Full-Service CRO PSI is expanding into Italy, South Africa and India as part of a push to gain a more global presence for clients.

OmniComm Partners with Clinverse to Offer Payment Tool as Part of EDC

04-Sep-2013 By Zachary Brennan

OmniComm Systems and Clinverse have partnered to combine OmniComm’s EDC system with Clinverse’s automated payment tool.

Private Equity Group Buys eClinical Firm Bracket

22-Aug-2013 By Gareth Macdonald

Private equity group Parthenon Capital Partners has acquired eClinical services firm Bracket from US pharmacy benefit management organization Express Scripts.

Acres, Vis and HealthCarePoint Say New Network Good for Sites and Sponsors

21-Aug-2013

A Non-profit group focused on reshaping the clinical research will have started registering research sites as part of an effort to set up a global network.

More CROs Using Loyalty Bonuses in Global "War for Talent"

19-Aug-2013 By Zachary Brennan

Globalization and high demand are prompting more CROs to add bonuses to retain and acquire talent.

Electronic Informed Consent: Will it Increase Patient Knowledge on Trials?

13-Aug-2013 By Zachary Brennan

As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data. 

Quintiles Posts Strong Quarterly Growth as Bookings Flatten Slightly

05-Aug-2013 By Zachary Brennan

CRO Quintiles last week announced its fourth consecutive quarter of at least $1B in net new business, as well as 13% growth in the second quarter of this year, though analysts said the company did not meet bookings expectations.

inVentiv Expands Medical Communications Business into Tokyo, New York

30-Jul-2013 By Zachary Brennan

inVentiv Health’s medical communications business is opening two new offices in Tokyo and New York City to be closer to clients and integrate further with the company’s clinical teams.

Update

CROs Press for More Adaptive Trials and Predict Surge in Demand

29-Jul-2013 By Zachary Brennan

Risk-averse sponsors are still slow to seek adaptive trial designs, but CROs building expertise in the field expect demand to increase.

Consistent Trial Site Payments Key to Long-Term Relationships with Investigators

25-Jul-2013 By Zachary Brennan

The days of using Excel spreadsheets to manage clinical trial site payments are now in the past, especially as CROs and sponsors look to retain their most highly-prized sites and establish long-term relationships for future trials.

Wuxi Buys Instem’s Remote Study Monitoring Tool

23-Jul-2013 By Zachary Brennan

China’s top CRO Wuxi Apptec has purchased a remote clinical trial monitoring tool that will allow its toxicology clients log onto a secure Web site to view data from on-going studies.

Accenture Looks to Compete with CROs in Accelerating Big Pharma R&D

22-Jul-2013 By Zachary Brennan

Accenture is using its consulting and tech expertise to corner the R&D service market with a slightly different style than CROs typically use.

Quintiles, PPD Lead List of CROs with Approved Global Trials in India

22-Jul-2013 By Zachary Brennan

Despite questions over India’s regulations governing clinical trials, the largest CROs in the world do not seem deterred from running trials there, according to a recently released list of global trial approvals from 2012. 

Comprehend Receives Finance for Clinical Data Insight Tech

22-Jul-2013 By Dan Stanton

Constantly evolving IT systems and tech innovations make clinical trial data harder to manage than manufacturing info, says Comprehend Systems.

PPD’s Monitoring of Eliquis Trials ‘Adequate’ says US FDA

18-Jul-2013 By Zachary Brennan

A US FDA investigation of CRO PPD did not uncover any violations that might prompt a Form 483 for its work related to Bristol-Myers Squibb’s approved drug, Eliquis.

Blackfield Wins Fourth Big Pharma IT Contract This Year

16-Jul-2013

Computational biology firm Blackfield has won its fourth Big Pharma contract in a year, with Anglo-Swedish drugmaker AstraZeneca signing up for its genomics services

Greenphire Teams Ask Ernst & Young to Shed Light on Sunshine Act

10-Jul-2013 By Gareth Macdonald

Ernst & Young (E&Y) analysts will try to illuminate the Sunshine Act for Greenphire's customers in the third collaboration the trial payment technology firm has signed in as many weeks.

Data Management Vendor’s Error Causes Cytokinetics to Revaluate ALS Trial

09-Jul-2013 By Zachary Brennan

Programming errors in a vendor's EDC system meant some patients were mistakenly given placebo during a trial of an ALS (amyotrophic lateral sclerosis) drug candidate being developed by Cytokinetics.

Lilly: Performance Metrics Key to CMO Management

03-Jul-2013 By Dan Stanton

Performance monitoring should be applied equally to external manufacturing as internal operations, says Eli Lilly.

Dispatches from DIA

DIA delegates welcome Cloudy forecast

26-Jun-2013 By Gareth Macdonald

Apparently some folks at DIA weren't discussing 'cloud-based' solutions this year but, as Outsourcing-pharma.com didn't find them, here's the news from those who are adding a little cumulonimbus to their blue-sky thinking.

Online Adverse Event Monitoring Could Guide Ph IV Spending say Researchers

24-Jun-2013 By Gareth Macdonald

Researchers behind a new automated adverse drug event monitoring method say it could act as an early warning system and guide Phase IV trials. 

Partnership Aims to Take Advantage of Preclinical Ophthalmology Developments

17-Jun-2013 By Zachary Brennan

Calvert Labs and EyeCRO have teamed up, citing growing demand for integrated early-phase services for ocular drugs.

Patheon Sees Revenue Increase in Q2 as CMO Business Thrives

13-Jun-2013 By Zachary Brennan

Canadian CMO Patheon’s second quarter revenues increased almost 40 percent as the company’s commercial manufacturing services revenues saw a similarly high rise over the same period from last year.

EU Data Protection Amendments Could Make Medical Research Impossible, Professors Say

11-Jun-2013 By Zachary Brennan

Epidemiological and other medical research could be prohibitively difficult to conduct if a new European regulation is passed, according to three professors from the University of Amsterdam.

AstraZeneca Selects IT Contractor for Three Neuroscience Trials

11-Jun-2013 By Zachary Brennan

AstraZeneca has chosen ePharmaSolutions to provide IT services for three separate neuroscience trials.

CROs Slowly Shifting to Adaptive Clinical Trial Designs

05-Jun-2013 By Zachary Brennan

As sponsors recognize the value of adaptive clinical trial designs and regulators come on board, CROs are beginning to shift their priorities to be more flexible.

QPS Selects Hepregen to Boost Preclinical Metabolism Services

05-Jun-2013 By Zachary Brennan

Hepregen has agreed to provide US CRO QPS Holdings with long-term liver cell models to aid its offerings in drug metabolism and pharmacokinetic (DMPK) services. 

Unither Acquires UCB Manufacturing, Packaging Plant in New York

04-Jun-2013 By Zachary Brennan

Unither has agreed to acquire UCB’s manufacturing and packaging facility in Rochester, New York, and will produce UCB products at the site.

Keys for CRO Partnerships: Expertise and Cycle Time Reductions, Expert Says

03-Jun-2013 By Zachary Brennan

Reducing cycle times and leveraging CRO expertise will drive sponsors’ decisions in choosing partners as they look to reduce costs and oversight obligations, according to a new report.

US FDA Recommends CMO Quality Agreements in Long-Awaited Draft Guidance

29-May-2013 By Zachary Brennan

Although written quality agreements are not required under cGMP regulations, the US FDA is recommending that pharma companies and CMOs adopt the agreements to delineate responsibilities.

Clinical Cymru Can Compete on Costs says PRA

15-May-2013 By Gareth Macdonald

PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.

Former RPS CIO's Lawsuit Claims Wrongful Termination

14-May-2013 By Zachary Brennan

Research Pharmaceutical Services' (RPS) former chief information officer (CIO) claims he was unfairly dismissed after discovering the CRO was unlawfully storing potential employees' personal data.

Executives Raise Questions on Clinical Trial Sponsors’ Oversight of CROs

13-May-2013 By Zachary Brennan

Tension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any time soon, but both sides seem intent on arriving at a middle ground where micromanagement stays low and the level of quality remains high.

PRA Expands Clinical Informatics, Adds New Facility in Wales

08-May-2013

CRO PRA has expanded its clinical informatics offerings and opened a new facility in Swansea, Wales, which will create a multi-lingual help desk, as well as offer 100 graduate-level jobs in data coordination, clinical programming and safety fields.

Ohio District Court Ruling Against Medpace Could Set Bar for MSAs

30-Apr-2013 By Zachary Brennan

With a ruling that could have implications for any CRO looking to understand its rights under a MSA (master services agreement) with a sponsor, a federal district court in Ohio has ruled against CRO Medpace.

ACRO Calls for Clarity on FDA Draft Guidance on eSource Trial Data

28-Mar-2013 By Zachary Brennan

ACRO (Association of Contract Research Organizations) is calling on the FDA to clarify draft guidance attempting to mitigate the possible pitfalls in transitioning to electronic source data for clinical investigations.

Dispatches from Outsourcing in Clinical Trials East Coast, Philadelphia

Merck, Eisai Reap Savings from Off-Shoring, Outsourcing in China and India

20-Mar-2013 By Zachary Brennan

Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.

FDA to Release Long-Awaited Guidance on CMO Agreements, Biosimilars in 2013

04-Feb-2013 By Zachary Brennan

Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).

JLL bids $123m for Bioclinica and plans imaging bolt-on

31-Jan-2013 By Gareth Macdonald

Bioclinica has agreed to a takeover by JLL Partners in a deal that would see the eClinical provider merge with medical imaging firm CoreLab Partners.