Regulatory affairs

Pharma’s dependence on legal departments, CROs to blame? ‘Common sense is completely gone out of research’

01-May-2019 By Melissa Fassbender

Clinical trials are less safe today as researchers are inundated with increasing amounts of data and new processes developed in part by CROs, which have created “tier upon tier of bureaucracy,” argues industry expert, who warns that things are getting...

'Not a minor misdemeanor': New report finds more than 80% of trials are still unreported

30-Apr-2019 By Melissa Fassbender

An international coalition of health integrity groups today demands that European universities must make clinical trial results public – with 83% all of due trials still unreported, according to a new report.

PopsiCube opens Russian affiliate to tap into international client base

29-Apr-2019 By Maggie Lynch

CRO PopsiCube opens strategic Russian affiliate to further its international expansion of clinical trial management and digital services.

Scaling down: Clinical research shifts its focus

29-Apr-2019 By Maggie Lynch

Smaller company’s last year led in new drug approvals, nearly half of which were for the treatment of rare diseases, as the industry shifts away from the need to scale infrastructure, says Tufts director.

Australia’s clinical trials industry is experiencing ‘unprecedented support’

29-Apr-2019 By Melissa Fassbender

The Australian Government commits $100m to support rural, regional, and remote clinical trials – recognizing the importance of a “vibrant clinical trial ecosystem in underpinning a world-class health care system,” says industry expert.

Biomarkers, pre-screened patient pools, and AI to increase productivity: Iqvia report

26-Apr-2019 By Melissa Fassbender

Biomarkers have the potential to improve drug development productivity by 34% over the next five years, during which period pre-screened patient pools and the application of predictive analytics also will help address the increasing complexity of clinical...

Patients, data, and making it all work together: Using RWD in research

23-Apr-2019 By Maggie Lynch

Using RWD and RWE to make data actionable and patient centric can be a gamechanger in the health care industry’s research capabilities, according to LMC Manna research executive.

WuXi and I-Mab extend partnership to accelerate biologic development

18-Apr-2019 By Maggie Lynch

I-Mab and WuXi Biologics extend their strategic partnership for biologics process development as well as clinical and commercial manufacturing to accelerate drug development in China and abroad.

All-digital clinical trial demonstrates the feasibility of siteless studies

17-Apr-2019 By Maggie Lynch

Virtual trials are poised to scale, says the CEO of Transparency Life Sciences, which recently conducted a siteless study to assess the feasibility and ease of collecting research-grade clinical data from subjects remotely.

CROs comment on FDA's new draft guidance for conducting natural history studies

16-Apr-2019 By Melissa Fassbender

Natural history studies provide researchers with a better understanding of a disease’s progression, supporting clinical trial design, among other benefits, say industry experts commenting on the FDA’s new draft guidance.

FDA’s project uses RWE to estimate trial results

15-Apr-2019 By Maggie Lynch

The FDA is advancing its project designed to determine the scientific validity and regulatory application of real-world evidence.

Pfizer partnership uses RWD to advance precision oncology

11-Apr-2019 By Maggie Lynch

Pfizer collaborates with Concerto HealthAI to advance precision oncology through the use of real world data.

WCG targets pain management, opioid alternatives in Analgesic Solutions deal

08-Apr-2019 By Maggie Lynch

WCG acquires Analgesic Solutions for advisement on protocol design and the development of clinical trials in which pain is an indicator of an underlying condition.

BMS taps Concerto HealthAI to bolster protocol design

08-Apr-2019 By Maggie Lynch

Bristol-Myers Squibb enters a multi-year strategic agreement with Concerto HealthAI to use machine learning to aid in protocol design for precision treatment and improved patient outcomes.

#TrialChat

An evolving discussion: ‘Clinical trial awareness cannot happen without all of us’

02-Apr-2019 By Melissa Fassbender

The discussion surrounding clinical trial awareness has evolved “from mere conversations to action, creativity, and inclusivity from multiple stakeholders,” and will continue to evolve as we work together to create a paradigm shift in awareness, says...

FDA offers further RBM guidance stressing data quality oversight

02-Apr-2019 By Melissa Fassbender

Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a new Q&A that reinforces the importance of performing risk assessments for all studies.

CROs ink exclusive partnership ‘to rapidly advance the field of otic research’

01-Apr-2019 By Melissa Fassbender

Sinclair Research and Turner Scientific sign an exclusive partnership through which the CROs will offer ototoxicity testing services – and improve regulatory guidance regarding the ears to protect patients, says company executive.

New consultancy targets ‘expansive global landscape’ for cell and gene therapies

01-Apr-2019 By Melissa Fassbender

Cell One Partners formally launches its consulting services and aims to be a long-term partner to its clients, supporting the development of cell and gene therapies – a market which raised more than $13.3bn in 2018.

People on the Move: Outsourcing-Pharma roundup March ‘19

29-Mar-2019 By Melissa Fassbender

The industry in March saw new c-suite appointments at CRF Bracket, PCI Pharma Services, George Clinical, and Paragon Bioservices – as well as moves to boost medical device and DMPK services at Premier Research and Sygnature Discovery, respectively.

Trialbee and Linical partner for patient-centric trial recruitment

28-Mar-2019 By Maggie Lynch

Trialbee and Linical Accelovance join forces for patient-centric clinical trials using digital innovations to establish a single point of contact to expedite clinical trial enrollment, retention, and speed-to-market solutions.

‘The UK may no longer be a country where bioanalytical innovation is feasible,’ says CRO on Brexit

28-Mar-2019 By Melissa Fassbender

Clinical trials in the UK are reportedly declining as the country grapples with Brexit – a change which could make access to preclinical and bioanalytical research materials, including NHPs, problematic, says QPS.

Science Exchange integrates WuXi LabNetwork into its marketplace

26-Mar-2019 By Maggie Lynch

WuXi LabNetwork enters an agreement with Science Exchange enabling users to order compounds directly following an increased demand for specialty chemicals.

Thermo Fisher acquires gene therapy CDMO Brammer Bio

25-Mar-2019 By Maggie Lynch

Thermo Fisher Scientific bolsters its gene therapy capabilities by acquiring Brammer Bio for $1.7bn, as the market becomes an ‘increasing focus’ for customers.

FDA eases ‘unnecessarily restrictive’ cancer clinical trial eligibility criteria

15-Mar-2019 By Melissa Fassbender

The FDA is addressing increasingly complex eligibility criteria in an effort to expand patient participation in cancer clinical trials, a move which will help shorten study recruitment timelines, among several other benefits to both researchers and patients,...

Funding for TriNetX totals $102m as the network expands globally

13-Mar-2019 By Maggie Lynch

TriNetX receives a total of $102m in a $40m Series D financing round as it continues to expand globally – looking to ‘spark a revolution,’ says CEO.

Regeneron releases ‘big data’ resource for global health research

11-Mar-2019 By Maggie Lynch

Regeneron and UK Biobank announce human sequencing data resource for global research and to accelerate improved patient care through outcome algorithms.

VirTrial joins SCRS to bolster remote trials

11-Mar-2019 By Maggie Lynch

Telehealth provider VirTrial joins SCRS as a partner enabling clinical trial stakeholders to bolster remote and virtual trial opportunities.

CTTI addresses patient, site engagement in latest mobile clinical trial recommendations

07-Mar-2019 By Melissa Fassbender

It is critical to understand the patient and site perspective to “maximize opportunities and minimize challenges” associated with the use of mobile technology in clinical trials, says CTTI executive director.

Ark Biosciences taps WuXI STA for CMC development

07-Mar-2019 By Maggie Lynch

WuXi AppTec subsidiary, STA Pharmaceutical partners with Ark Biosciences for CMC development of RSV therapy.

AG Mednet builds on Judi platform to streamline DSMB information

07-Mar-2019 By Maggie Lynch

AG Mednet releases Judi DSMB as a solution for securing and automating data safety monitoring board activities and documents.

IRB consolidation: Advarra acquires Quorum Review and Kinetiq

05-Mar-2019 By Melissa Fassbender

The institutional review board industry sees further consolidation as Advarra acquires Quorum and its research and technology consulting division, Kinetiq.

People on the Move: Outsourcing-Pharma roundup February ‘19

01-Mar-2019 By Melissa Fassbender

Parexel boosts its oncology team, Premier Research has a new COO joining from PPD, and SGS names a new biologics manager, among other new hires in February.

Boyds opens new office in Ireland, an ‘insurance policy’ ahead of Brexit

25-Feb-2019 By Melissa Fassbender

The pharmaceutical and biotech consultancy has opened a new office in Dublin, Ireland ahead of Brexit, the final outcomes of which remain unknown, says CEO.

SCOPE 2019

Sites challenged with fragmented processes that ‘drain resources’

21-Feb-2019 By Maggie Lynch

Clinical trial sites are challenged by fragmented financial processes, according to a new study by the Society of Clinical Research sites and Greenphire released this week at SCOPE 2019.

PPD signs exclusive agreement with China-based AI company

21-Feb-2019 By Melissa Fassbender

PPD’s agreement with China-based Happy Life Tech focuses on site selection, patient recruitment, and real-world evidence generation for customers globally.

AI threatens health data privacy: Report

19-Feb-2019 By Melissa Fassbender

Artificial intelligence advances threaten data privacy, according to a new study, which found it is possible to re-identify individuals using their physical activity data.

SCOPE 2019

Oracle integrates Quorum IRB tech to smooth submission process

19-Feb-2019 By Melissa Fassbender

The collaboration between Quorum Review IRB and Oracle goBalto removes the need to send IRB submission documents manually.

SCOPE 2019

Shimmer shines with a new wearable platform for clinical trials

19-Feb-2019 By Melissa Fassbender

Shimmer designed its new Verisense platform from the ground up after finding that current activity trackers fail to meet the “basic needs of the clinical research market,” says company executive.

EMA implored to improve trial reporting, with over 50% of trials still missing results

18-Feb-2019 By Melissa Fassbender

The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”

SCOPE 2019

Tech is advancing, but uncertainty creates an ‘opposing effect’ to positive movement

18-Feb-2019 By Melissa Fassbender

The industry has advanced to a point that should justify the financial investment in new technology, though uncertainty, and a lack of support, are hindering movement.

Lonza utilizes global network for CBD-based drug manufacture

18-Feb-2019 By Maggie Lynch

Lonza and Emerald Health enter an agreement for the large-scale manufacturing of a synthetic derivative of CBD and its oral drug product for the treatment of MS and other CNS diseases.

‘Couldn’t do it without technology’: Embracing clinical software for trial recruitment

15-Feb-2019 By Maggie Lynch

Getting patients into possibly life-saving trials has long been a complex process, however, with the age of electronic health records and cloud-based data, there are opportunities for simplification.

Icon introduces new drug safety reporting solution

11-Feb-2019 By Melissa Fassbender

Icon’s new drug safety reporting platform automates complex processes to ensure compliance in the ‘ever-changing’ regulatory environment, says VP.

PE firm's £459m capital fund invests in growing CRO

07-Feb-2019 By Maggie Lynch

The UK-based private equity firm CBPE has purchased a majority stake in Simbec-Orion and will expand the CRO's reach both geographically and across all business units.

TrialAssure discounts pricing for academics: ‘It is crucial for universities to get it right’

04-Feb-2019 By Melissa Fassbender

The global software provider is discounting its reporting software for academics, as universities globally struggle with compliance and face increasing pressure to publish clinical trial results.

Wasdell gets HPRA nod at its new EU headquarters

28-Jan-2019 By Melissa Fassbender

The Wasdell Group’s new EU headquarters in Dundalk, Ireland is set to commence operations later this year as part of the company’s “proactive contingency plan” ahead of Brexit.

Sartorius Stedim BioOutsource adds NBE product characterization to service lineup

24-Jan-2019 By Melissa Fassbender

Sartorius Stedim Biotech’s contract testing subsidiary is adding services offer increased support to clients developing new biological entities.

‘Sit up and take notice’: UK Parliament clamps down on universities not reporting clinical trial results

24-Jan-2019 By Melissa Fassbender

The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.

Quanticate bolsters PV service platform

22-Jan-2019 By Maggie Lynch

Quanticate is bolstering its pharmacovigilance services with a recent addition to its risk management platform.

Health care consulting firm Vynamic opens new office in London

22-Jan-2019 By Melissa Fassbender

With offices in Philadelphia and Boston, Vynamic’s London office – co-located with STEM Healthcare – is the company’s first outside the US as it looks to support existing and new clients globally.