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Headlines > February 2017

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rare disease day 2017

PPD combines rare disease and pediatrics in new 'Center of Excellence'

28-Feb-2017 - The new center of excellence provides PPD clients with a team dedicated to clinical studies in rare disease and pediatric patient populations.

News in brief

Premier Research adopts ERT for enhanced oversight

28-Feb-2017 - Premier Research has selected ERT’s Trial Oversight suite as its clinical trial management solution to augment sponsor collaboration and help mitigate risk.

Rare disease day 2017

Are we moving fast enough? ARG talks rare disease clinical trials

28-Feb-2017 - Researchers and patients have more efficient tools for sharing information on rare diseases, and as knowledge continues to spread, rare disease studies will become less rare.

Rare disease day 2017

Infographic: Rare disease research

28-Feb-2017 - Approximately 400 clinical trials in a rare disease condition are currently registered on ClinicalTrials.gov – on Rare Disease Day 2017, Outsourcing-Pharma.com examines the numbers.

PEOPLE ON THE MOVE

Outsourcing-Pharma's Hiring and Firing Roundup February '17

28-Feb-2017 - Outsourcing-Pharma presents this month's roundup of who is moving where in the contract research and manufacturing industry.

GBSI report outlines steps to improve preclinical research reproducibility

27-Feb-2017 - The Global Biological Standards Institute (GBSI) has outlined an action plan after finding the frequency of irreproducible preclinical research exceeds 50% – costing the US nearly $28bn.

PHARMA OUTSOURCING & PARTNERSHIP GLOBAL CONGRESS 2017 EUROPE

Biogen provides 'relationship advice' for outsourcing in pharma

27-Feb-2017 - Partner relationships should start with the long-term in sight – just like a marriage, says Biogen.

News in brief

QPS tapped for Acticor Biotech FIH study

27-Feb-2017 - Acticor Biotech has contracted QPS to manage a Phase I study of the company’s humanized Antibody Fragment, ACT017.

Pharma Outsourcing & Partnership Global Congress 2017 Europe

Vital statistics? Big Pharma undervaluing commercial data, expert

27-Feb-2017 - Data is a core competence for Big Pharma that should not be outsourced, according to an industry statistics expert.

INC Research expands FSP services

27-Feb-2017 - INC Research has expanded its Functional Service Provider (FSP) service offering to include investigator payment processing in response to increased transparency requirements.

QuintilesIMS eyes revenue growth with refinancing

23-Feb-2017 - QuintilesIMS has announced an offering of senior notes and a proposed debt refinancing as leadership looks to drive revenue growth, according to a Jefferies analyst.

Envigo thyroid hormone assay meets OECD guidelines

23-Feb-2017 - Envigo has developed and validated an analytical method to evaluate the potential effects of thyroid hormone levels in rat F1 offspring.

Ohr Pharmaceutical Inc. shuts sustained release tech lab

23-Feb-2017 - Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.

Gov’t delay could postpone ClinicalTrials.gov usability, patient recruitment

23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start...

Evotec taps into Oxford innovation through £13m grant scheme

22-Feb-2017 - Dubbed LAB282, the £13m (€15M) Oxford University drug discovery program with Evotec has announced two grant winners and a second set of awards of up to £250,000.

PPD collaborating with nephrology expert Frenova

22-Feb-2017 - Pharmaceutical Product Development, LLC (PPD) is expanding its therapeutic expertise through a new collaboration with Frenova Renal Research.

Bioclinica: more stakeholders pushes need for collaboration

22-Feb-2017 - Bioclinica has expanded its eHealth App xChange to make a greater range of technologies available to the increasing number of industry stakeholders – many with differing priorities. 

iCardiac eCOA platform a 'major step forward,' says CEO

22-Feb-2017 - iCardiac’s new eCOA platform, QPoint, can measure clinical outcome assessments from patients at home or during site visits and will soon integrate with emerging wearables.

Icon awarded FDA project to validate PRO instruments

21-Feb-2017 - The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

News in brief

JSS uses EnduraData cloud to link up Canada and Colombia

21-Feb-2017 - The CRO JSS Medical Research will use EnduraData’s cloud tool to synchronize medical research data between servers in Canada and Colombia, South America.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 - Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

Belgian CRO launches EU joint venture with Chromatography Institute

20-Feb-2017 - The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.

CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

EMA: GCP deviations increasing

20-Feb-2017 - The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.

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