Clinical Development Strategy & Clinical Trials Support

Leverage our seasoned drug development physicians to define your clinical strategy and manage your clinical trials.

Our clinical consulting team is led by seasoned pharmaceutical physicians with many years of drug development experience. Combined with our expert network we're able to provide extensive and precisely-tailored expertise to support you with planning and implementing clinical development programs, across a broad range of therapeutic areas and product modalities including small molecules, biologics, and cell and gene therapies.


Clinical Strategy & Clinical Trial Design Services
  • Developing target product profiles
  • Clinical development strategy & plans
  • Developing study synopses and trial protocols
  • Clinical trials benchmarking
  • Disease indication strategy and lifecycle management
  • Statistical Analysis Plans and Biostatistics Support
Clinical Operations
  • Clinical operations support (CRO and site management)
  • Resolving recruitment issues
  • Clinical Quality Assurance and cGCP compliance
Regulatory 
  • Defining regulatory strategy and optimal pathways
  • ODD, FTD, Breakthrough, Priority Review applications
  • IND and NDA/MAA/BLA readiness analysis
  • Providing strategic or hands-on support for interacting with the FDA and EMA
  • Preparing dossiers and submissions


When building a project team, in addition to our core consultants, we draw from an expert network of over 500 highly-experienced functional specialists. This allows us to provide clients with the exact expertise their clinical development projects require, from strategy to hands-on drug development and clinical operations support to regulatory affairs.

Many of our consultants have made significant contributions to the development of launched products and have held global responsibilities for marketed medicines. Our support spans most strategic aspects of clinical development as well as operational support on a selective basis. Although Alacrita is not a CRO, team members often manage CRO activities on behalf of clients, serving as an interface to ensure enrollment issues are managed proactively and that results are delivered as expected - something that can be crucial when a mismatch exists between the size of the CRO and the size of the client. 

By engaging Alacrita, you can access high-caliber clinical trials professionals more rapidly than building an internal team, allowing early-stage enterprises to push forward efficiently and effectively with drug development. Our large pharma clients frequently engage us to augment existing teams during periods of rapid growth.


Interim Chief Medical Officer 

Alacrita has a number of CMO-level clinical MDs in our expert network. We sometimes support our biotech clients with an interim Chief Medical Officer, during, for example, periods of extended search for a full-time individual. These Alacrita consultants are capable of overseeing flagship clinical trials, guiding a portfolio of programs, providing leadership to junior medics in the organization, as well as representing the company with the board of directors, investors and regulatory authorities.


Recent Clinical Development Projects:

  • Regulatory Interim Chief Medical Officer for fibrosis company: A well-capitalized, private biotech company with a drug discovery platform identified multiple first-in-class and best-in-class compounds targeting critical pathways widely involved in inflammatory and fibrotic diseases. As lead compounds progressed toward the development phase, the company was considering a broad spectrum of disorders as initial and follow on targets for therapy, including liver fibrotic disorders, idiopathic pulmonary fibrosis, renal fibrosis, and inflammatory bowel disease. The company desired a chief medical officer (CMO) with deep development experience in the broad area of fibrotic disease including liver, gastrointestinal, renal, and lung disease and organizational experience in the roles and responsibilities of a CMO.

  • Regulatory Development support for first-in-class pediatric oncology drug: For a listed US biotech company with marketed products, Alacrita's pediatric oncologist consultant provided ongoing support with Phase I/II design, protocol development and medical oversight of a first-in-class oncology drug for a pediatric population. The drug mechanism has an immunotherapy modality and continues to be investigated in clinical trials.

  • Regulatory Providing clinical and medical support in immuno-oncology: A leading immuno-oncology biotech company with a pipeline of novel, first-in-class clinical stage assets needed medical support for multiple clinical and medical affairs activities in Europe and the United States. Our support included providing advice and assistance with the following:
      • clinical strategy and execution of the clinical development plans for the company’s drug candidates
      • drug safety and pharmacovigilance
      • fostering existing and future relationships with key opinion leaders, medical advisors and medical advisory boards.
      • We also assessed portfolio expansion opportunities and other corporate development activities from a clinical development and medical perspective.

  • Regulatory pathway for new wound care products: A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care and had mapped regulatory pathways relating to various classes of product. Having identified various paradigms for currently marketed products in the US including 510(k), Class III PMA, banked human tissue, Biologics License Application, and New Drug Application, the company needed to understand the corresponding regulatory pathways in Europe, and the regulatory requirements for bringing three of its products to market.

  • Independently reviewing clinical trial data: A small biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s management and board of directors.  Due to an upcoming board meeting, this request had a tight deadline of only six days from the initial transfer of data to submission of the final report.

  • Chief Medical Officer support for listed biotech: A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United States. We provided medical oversight of three ongoing clinical trials, in particular, providing medical oversight for a Phase I trial in preparation for a marketing application, a data and safety measurement board (DSMB) review of an ongoing Phase IIb clinical trial, and the launch of a Phase II clinical study in pancreatic cancer.


Selection of Clinical Development Case Studies:


Defining a Clinical Strategy in Oncology

Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations.

Solution: Our oncology consultant created a detailed timeline and gap analysis for the company’s initial IND filing and Phase 0-l clinical trial launch, and conducted the following tasks.

  • Reviewed relevant documents, including the technology, pre-existing corporate, scientific and clinical goals, and any preclinical data

  • Held interviews with key stakeholders including company founders, the CEO and the internal R&D team

  • Reviewed potential target cancer indications and establishing up-to-date standards of care

  • Reviewed relevant biomarkers to inform PK/PD activity and patient enrichment strategies

  • Prepared a clinical development plan including prioritization of target indications, design of Phase 0-lla clinical trials and proposal for clinical trial investigators and sites

  • Developed an interval-to-IND filing gap analysis.

Our consultant presented to the board and was retained as an ongoing medical advisor to the company. Further case studies regarding the work Alacrita performs in clinical development are available here.

 

Interim Medical Director for Neuroendocrine EU MAA submission

Challenge: For a European pharmaceutical company, a highly-experienced Alacrita consultant with a background in endocrine and metabolic therapies acted as medical director for the registration of a new agent in a neuroendocrine indication in territories outside the USA. Alacrita was brought in by the client five months before the planned MAA submission date after the internal medical director and other key team members unexpectedly left the company and could not be replaced internally.

Solution: During the five-month period, the team finalized the study reports, wrote the overview and the SmPC for the submission as well as preparing an ODD application (which was granted). The team received numerous questions from the rapporteur and co rapporteur and the same team worked on the responses to questions, including new statistical analyses of the clinical data. The Alacrita medic represented the company in regulatory agency meetings and the product was successfully steered through regulatory approval. Following this, submissions were prepared for other non-US territories and the dossier was transitioned to the client’s commercial team.


Recent White Paper:


  • FDA Expedited Programs for Cancer Drug Development: Don’t Believe the Doubters

    Approximately 40% of recently approved cancer drugs have gone through one of four established FDA expedited programs. These treatments account for billions of dollars in sales and help create a thriving, industry-wide pipeline. The FDA has also recently approved the first New Drug Application (NDA) under one of its new pilot programs intended to speed cancer drug review, leading to optimism that these programs will also help speed delivery of more drugs to patients. But there has also been fresh criticism about results of the Accelerated Approval pathway and whether post-market trials support approval of most of these drugs. Will concerns about overuse lead to curtailment of these programs? Or do these concerns just reflect the age-old tension between getting drugs approved faster and knowing more about them before they are approved? Have criteria for what makes a good candidate for an expedited program changed? Here, we review the latest developments with insights and comments from Dr. William (Bill) Slichenmyer, a partner at Alacrita and an oncologist with more than 20 years of experience in the biopharma industry.

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