Specialist Medical Writing Partners: the best of both worlds?
As the popularity of outsourced medical writing continues to increase in the Life Sciences industry, partnering with the correct type of vendor is crucial for the successful and efficient development of submission-ready documents. Clinical operations, regulatory affairs, clinical trial managers… the list of roles involved in the outsourcing of medical writing goes on. Many biotech…
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Morula Health
Repeatedly Unlocking Success: West Coast Biotech successfully prepared for their Type B Meeting with timely technical support
Background One of our repeat clients, a West Coast Biotechnology company, needed help with writing and strategic input for their Meeting Request Letter and Briefing Book. This was in preparation for a Type B Meeting with the FDA following a preliminary Breakthrough Therapy Designation Request (BTDR), Preliminary Meeting and Type A Meeting. Challenge The preparation…
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Morula Health
Morula Health Charity Donation 2022
Throughout 2022 Morula Health has contributed to the development of many pioneering therapeutics targeting life-limiting diseases such as neurogenerative disorders and cancers. Many of these therapeutics would not exist if it weren’t for the tireless work of charities, and the academic research they fund. We are humbled by the symbiotic relationship within which we exist.…
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Morula Health
Quite Complicated or Quite Clear: Tips for creating a smooth QC process
What is QC and why is it helpful? Many of our clients opt for Quality Control (QC) as part of their writing process. During QC, a second Medical Writer reviews and proofreads documents. Following a well-defined process, they ensure that the work is well-formatted and follows a consistent style throughout to meet regulatory standards, resulting…
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Morula Health
IND to IMPD Adaptation to Open Sites in Europe and Israel
Morula Health’s expertise and quick solution allowed for easy adaptation of an IND to IMPD for one of our clients.
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Morula Health
Reduce Start-Up and Improve CRO Selection Process
Morula Health’s innovative Medical Writing strategy to help reduce start-up and improve CRO selection process. Current Process / Challenges Biotech companies adopting a full-service or hybrid outsourcing model sometimes include the writing of core clinical trial documentation as part of the Request for Proposal (RFP) scope of services. It means the writing of these documents…
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Morula Health
Engage patients and create a patient centric protocol with The Lean Startup
COVID-19 has forced an industry-wide adoption of decentralized clinical trials and increased public awareness of clinical research, and the need for patient participation. This combination has created a unique opportunity to increase patient involvement in the design of clinical trials and then implement these patient-centric trials with the widely adopted methods we now have in…
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Morula Health
Experience matters when it comes to medical writing
Experience is an important metric for qualifying and selecting outsourcing partners for biotech and pharma, regardless of whether it is full-service outsourcing or medical writing services. Readers of RFIs/RFPs will be familiar with experience-related statements such as 25 oncology medical writing projects in the last five years, 15 medical writers with relevant neurology experience, 18…
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